MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383732

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Pain (1994); Chills (2191)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system was used to deliver "ns100ml + 1.2 g of reduced glutathione", and the patient felt "faint pain" at the injection site the next day.No redness or swelling was noted.Six days later, the patient complained of "fever" with a body temperature of "38.6 ° c".A blood culture was taken, as well as ibuprofen tablets, and temperature decreased.The following day, the patient's temperature elevated up to "37.0".There was still no redness or swelling observed at the puncture site, and "ns100ml + reduction type guguang for injection glycine 1.2g liver protection treatment" was administered.Later that day, however, the patient complained of chills and pain at the puncture site, with a temperature of "40.8 ° c".An urgent blood culture check was done, as well as a "blood routine, 1 tablet of ibuprofen, oral medical physics", and the body temperature dropped to "37.8".The following day, pain was complained about again.Body temperature had risen back to "39.6", more ibuprofen was given, and the body temperature "gradually decreased" after.The following day, "redness, swelling, and pain" was noted in the patient's veins, and the doctor advised a "symptomatic treatment" of "topical application of polysulfonic mucopolysaccharide cream and wet application of magnesium sulfate" to be used.A "doppler ultrasound" was also administered, with the results "suggesting" a "solid hypoechoic subcutaneous vein in and around the right forearm" about "38.8mm, with the possibility of "thrombosis and inflammation".The lab emergency department reported "acinetobacter baumannii" from the blood culture, and an emergency consultation with the "gastrointestinal and peripheral vascular surgery and general intervention" department was done.Surgery was decided against; instead, "oral administration to diosmin, swelling of the affected area with magnesium sulfate wet compress" and "topical xiliaotuo topical, natriheparin calcium anticoagulation therapy (1 q12h), regular review of color doppler ultrasound" was advised.The doctor prescribed "polysulfonic mucopolysaccharide cream" and "magnesium sulfate" be applied topically to the area, "diosmin" be taken orally, "ceftazidime intravenous anti-infection" be administered, and "naltreparin calcium anticoagulation and other symptomatic treatments" be performed.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2019, in order to avoid repeated puncture of the blood vessels of the patient, a venous indwelling needle was given to the patient.At 17:45 on (b)(6) 2019, ns100ml + 1.2 g of reduced glutathione for injection were given intravenously.At 18:25 on (b)(6) 2019, the patient reported faint pain at the injection site.After checking the puncture site of the indwelling needle, there was no obvious redness, swelling, and pain.The fixation was stable and continued observation.The patient did not report any discomfort at the indwelling needle.On (b)(6) 2019, at 21:20, the patient complained of fever, taking a body temperature of 38.6 ° c, and taking blood culture, ibuprofen tablets orally according to the doctor's order, and the temperature gradually decreased after treatment.On (b)(6) 2019 01:40, the body temperature was 37.0.(b)(6) 2019 08:43 before the patient was infused, check that the patient's vein indwelling needle has no obvious redness, swelling and pain, and the surrounding skin is normal.The indwelling needle is securely fixed, and the tube is smooth.Continue to follow the doctor's advice to ns100ml + reduction type guguang for injection glycine 1.2g liver protection treatment the end of the infusion at 09:17, the infusion process was smooth, and the patient had no complaints.At 10:10 on (b)(6) 2019, i complained of chills, pain at the indwelling needle, and immediately kept warm, taking a body temperature of 40.8 ° c.After reporting to the doctor in charge, he performed an urgent blood culture check, blood routine, 1 tablet of ibuprofen, oral medical physics after cooling down and other treatments, the body temperature dropped to 37.8.The patient did not report any pain at the indwelling needle and was observed.At 18:45 on (b)(6) 2019, the patient complained of pain at the indwelling needle.If he saw a slight redness at the indwelling needle, the indwelling needle was removed.(b)(6) 2019 19:44 body temperature 39.6, ibuprofen was given orally, and the temperature gradually decreased after treatment.On (b)(6) 2019, at 09:00, check the patient's veins for indwelling needles with redness, swelling and pain.Report to the doctor in charge and follow the doctor's advice to give symptomatic treatment such as topical application of polysulfonic mucopolysaccharide cream and wet application of magnesium sulfate.Check the superficial part for color doppler ultrasound, ultrasound results suggest a solid hypoechoic subcutaneous vein in and around the right forearm, the possibility of thrombosis and inflammation, the length is about 38.8mm, 11:19 report from the emergency department of the laboratory, blood culture (two bottles) hint: acinetobacter baumannii.Gastrointestinal and peripheral vascular surgery and general interventional department emergency consultation are invited.The gastrointestinal and peripheral vascular surgery consultation is no indication of surgery.Oral administration to diosmin, swelling of the affected area with magnesium sulfate wet compress, and general interventional department consultation for anti-infection, topical xiliaotuo topical, natriheparin calcium anticoagulation therapy (1 q12h), regular review of color doppler ultrasound.Follow the doctor's advice to apply polysulfonic mucopolysaccharide cream externally and apply magnesium sulfate to the affected area.Diosmin is taken orally, ceftazidime intravenous anti-infection, naltreparin calcium anticoagulation and other symptomatic treatments.Continue to monitor body temperature and observe the skin condition of the indwelling needle.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9081789.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system was used to deliver "ns100ml + 1.2 g of reduced glutathione", and the patient felt "faint pain" at the injection site the next day.No redness or swelling was noted.Six days later, the patient complained of "fever" with a body temperature of "38.6 ° c".A blood culture was taken, as well as ibuprofen tablets, and temperature decreased.The following day, the patient's temperature elevated up to "37.0 ¿".There was still no redness or swelling observed at the puncture site, and "ns100ml + reduction type guguang for injection glycine 1.2g liver protection treatment" was administered.Later that day, however, the patient complained of chills and pain at the puncture site, with a temperature of "40.8 ° c".An urgent blood culture check was done, as well as a "blood routine, 1 tablet of ibuprofen, oral medical physics", and the body temperature dropped to "37.8 ¿".The following day, pain was complained about again.Body temperature had risen back to "39.6 ¿", more ibuprofen was given, and the body temperature "gradually decreased" after.The following day, "redness, swelling, and pain" was noted in the patient's veins, and the doctor advised a "symptomatic treatment" of "topical application of polysulfonic mucopolysaccharide cream and wet application of magnesium sulfate" to be used.A "doppler ultrasound" was also administered, with the results "suggesting" a "solid hypoechoic subcutaneous vein in and around the right forearm" about "38.8mm, with the possibility of "thrombosis and inflammation".The lab emergency department reported "acinetobacter baumannii" from the blood culture, and an emergency consultation with the "gastrointestinal and peripheral vascular surgery and general intervention" department was done.Surgery was decided against; instead, "oral administration to diosmin, swelling of the affected area with magnesium sulfate wet compress" and "topical xiliaotuo topical, natriheparin calcium anticoagulation therapy (1 q12h), regular review of color doppler ultrasound" was advised.The doctor prescribed "polysulfonic mucopolysaccharide cream" and "magnesium sulfate" be applied topically to the area, "diosmin" be taken orally, "ceftazidime intravenous anti-infection" be administered, and "naltreparin calcium anticoagulation and other symptomatic treatments" be performed.The following information was provided by the initial reporter, translated from chinese to english: "on october 17, 2019, in order to avoid repeated puncture of the blood vessels of the patient, a venous indwelling needle was given to the patient.At 17:45 on october 17, 2019, ns100ml + 1.2 g of reduced glutathione for injection were given intravenously.At 18:25 on october 23, 2019, the patient reported faint pain at the injection site.After checking the puncture site of the indwelling needle, there was no obvious redness, swelling, and pain.The fixation was stable and continued observation.The patient did not report any discomfort at the indwelling needle.On october 23, 2019, at 21:20, the patient complained of fever, taking a body temperature of 38.6 ° c, and taking blood culture, ibuprofen tablets orally according to the doctor's order, and the temperature gradually decreased after treatment.On october 24, 2019 01:40, the body temperature was 37.0 ¿.October 24, 2019 08:43 before the patient was infused, check that the patient's vein indwelling needle has no obvious redness, swelling and pain, and the surrounding skin is normal.The indwelling needle is securely fixed, and the tube is smooth.Continue to follow the doctor's advice to ns100ml + reduction type guguang for injection glycine 1.2g liver protection treatment the end of the infusion at 09:17, the infusion process was smooth, and the patient had no complaints.At 10:10 on october 24, 2019, i complained of chills, pain at the indwelling needle, and immediately kept warm, taking a body temperature of 40.8 ° c.After reporting to the doctor in charge, he performed an urgent blood culture check, blood routine, 1 tablet of ibuprofen, oral medical physics after cooling down and other treatments, the body temperature dropped to 37.8 ¿.The patient did not report any pain at the indwelling needle and was observed.At 18:45 on october 24, 2019, the patient complained of pain at the indwelling needle.If he saw a slight redness at the indwelling needle, the indwelling needle was removed.October 24, 2019 19:44 body temperature 39.6 ¿, ibuprofen was given orally, and the temperature gradually decreased after treatment.On october 25, 2019, at 09:00, check the patient's veins for indwelling needles with redness, swelling and pain.Report to the doctor in charge and follow the doctor's advice to give symptomatic treatment such as topical application of polysulfonic mucopolysaccharide cream and wet application of magnesium sulfate.Check the superficial part for color doppler ultrasound, ultrasound results suggest a solid hypoechoic subcutaneous vein in and around the right forearm, the possibility of thrombosis and inflammation, the length is about 38.8mm, 11:19 report from the emergency department of the laboratory, blood culture (two bottles) hint: acinetobacter baumannii.Gastrointestinal and peripheral vascular surgery and general interventional department emergency consultation are invited.The gastrointestinal and peripheral vascular surgery consultation is no indication of surgery.Oral administration to diosmin, swelling of the affected area with magnesium sulfate wet compress, and general interventional department consultation for anti-infection, topical xiliaotuo topical, natriheparin calcium anticoagulation therapy (1 q12h), regular review of color doppler ultrasound.Follow the doctor's advice to apply polysulfonic mucopolysaccharide cream externally and apply magnesium sulfate to the affected area.Diosmin is taken orally, ceftazidime intravenous anti-infection, naltreparin calcium anticoagulation and other symptomatic treatments.Continue to monitor body temperature and observe the skin condition of the indwelling needle.".

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9574884
• MDR Text Key: 188216019
• Report Number: 8041187-2019-01081
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 383732
• Device Lot Number: 9081789
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention