MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381812

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

Patient Problems Abscess (1690); Sepsis (2067); Skin Discoloration (2074)

Event Date 08/25/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that after use of the bd insyte¿ autoguard¿ shielded iv catheter, neonatal sepsis developed in , 36-week pre term male.Neonatologist is informed and orders to initiate oxacillin and soft tissue ultrasound.The following information was provided by the initial reporter, translated from spanish to english: nursing assistant reports on infectious process at the site of venipuncture in the upper left limb, erythema and blush are observed, however there are no changes at the hemodynamic level, a pediatrician on duty is notified, nursing management is given, it is related to a venipuncture device , intravenous catheter # 24.The incident was noticed during the use.There was a abscess in the arm of the patient caused probably by the catheter.The patient passed by a treatment to this infection.In turn neonatologist is informed who orders to initiate oxacillin and soft tissue ultrasound neonatal sepsis, suspected metabolic disease, 36-week pre term born: (b)(6) 2019 and that same day he entered the neonatal unit.Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019 - epicutaneous catheter - upper left limb - administration of: intravenous fluids, vancomycin and meropenem.Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019 - short peripheral catheter 24g - upper left limb - patient with laboratory order whereby nursing leaves catheter installed with venous connector and immobilized with adhesive tape (affix cloth).And on (b)(6) in the note of receipt of shift there is no description of signs of phlebitis or signs of infection, however, at 20:30 hrs there is a nursing note that describes the signs of infection at the site of puncture.In turn neonatologist is informed who orders to initiate oxacillin and soft tissue ultrasound taking attached to the report.Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019 - short peripheral catheter 24g - upper left limb - blood culture and start of oxacillin.Insertion: (b)(6) 2019; withdrawal: (b)(6) 2019- short peripheral catheter 24g - upper left limb - oxacillin administration, without continuous liquids.Insertion: (b)(6) 2019 tn; to the present ((b)(6) 2019) - short peripheral catheter 24g - upper left limb - oxacillin administration, without continuous liquids.At the moment with extension, connected to infusion set and infusion pump turned off, no use of needle-free connector, the access is currently covered with adhesive tape (cloth fixomull).Patient currently without skin lesions due to previous punctures, additionally the nurse (late shift), who is currently assigned to this patient reports that since admission to the neonatal unit the patient has remained with a mottled skin appearance, which does not change with the administration of its antibiotic treatment and its saturation has remained above 90%.

Manufacturer Narrative

Investigation summary: observations and testing could not be performed because units were not received for investigation of this incident.One photo was submitted which displayed a memo in another language.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Conclusion(s): indeterminate: without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

Event Description

It was reported that after use of the bd insyte¿ autoguard¿ shielded iv catheter, neonatal sepsis developed in , 36-week pre term male.Neonatologist is informed and orders to initiate oxacillin and soft tissue ultrasound.The following information was provided by the initial reporter, translated from spanish to english: nursing assistant reports on infectious process at the site of venipuncture in the upper left limb, erythema and blush are observed, however there are no changes at the hemodynamic level, a pediatrician on duty is notified, nursing management is given, it is related to a venipuncture device, intravenous catheter # 24.The incident was noticed during the use.There was a abscess in the arm of the patient caused probably by the catheter.The patient passed by a treatment to this infection.In turn neonatologist is informed who orders to initiate oxacillin and soft tissue ultrasound neonatal sepsis, suspected metabolic disease, 36-week pre term born: (b)(6) 2019 and that same day he entered the neonatal unit.- insertion: (b)(6) 2019; withdrawal: (b)(6) 2019 - epicutaneous catheter - upper left limb - administration of: intravenous fluids, vancomycin and meropenem.- insertion: (b)(6) 2019 ; withdrawal: (b)(6) 2019 - short peripheral catheter 24g - upper left limb - patient with laboratory order whereby nursing leaves catheter installed with venous connector and immobilized with adhesive tape (affix cloth).And on august 25 in the note of receipt of shift there is no description of signs of phlebitis or signs of infection, however, at 20:30 hrs there is a nursing note that describes the signs of infection at the site of puncture.In turn neonatologist is informed who orders to initiate oxacillin and soft tissue ultrasound taking attached to the report.- insertion: (b)(6) 2019 ; withdrawal: (b)(6) 2019 - short peripheral catheter 24g - upper left limb - blood culture and start of oxacillin.- insertion: (b)(6) 2019 withdrawal: (b)(6) 2019 - short peripheral catheter 24g - upper left limb - oxacillin administration, without continuous liquids.- insertion: (b)(6) 2019 tn; to the present ((b)(6) 2019) - short peripheral catheter 24g - upper left limb - oxacillin administration, without continuous liquids.At the moment with extension, connected to infusion set and infusion pump turned off, no use of needle-free connector, the access is currently covered with adhesive tape (cloth fixomull).Patient currently without skin lesions due to previous punctures, additionally the nurse (late shift), who is currently assigned to this patient reports that since admission to the neonatal unit the patient has remained with a mottled skin appearance, which does not change with the administration of its antibiotic treatment and its saturation has remained above 90%.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9086570
• MDR Text Key: 163605478
• Report Number: 1710034-2019-01018
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 381812
• Device Lot Number: 9037525
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 DA