MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383912

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

Patient Problems Erythema (1840); Swelling/ Edema (4577)

Event Date 08/14/2022

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 patient developed an edema with swelling and redness in the site the was placed.As a result, damp, magnesium sulfate heat and potato chips were applied to the affected area, closed with phentolamine and treated with oxygen.The following information was provided by the initial reporter, translated from chinese: "the patient's blood pressure was low at 03:47, 66/35mmhg.Notify the doctor and follow the doctor's instructions to speed up the infusion rate.At 04:19, he was given gs50ml + nor 8mg, micropumped at 3ml/h, and the vein was reset at 06:00 on august 14th.The indwelling needle was placed on the back of the left hand, the nail pump was continuously removed, and the pump was micro-pumped at 4ml/h, and the blood returned smoothly after the shift at 8:00.Close observation.Edema appeared in the left arm, and the intravenous indwelling needle was re-inserted at 16:00, and the indwelling needle on the back of the left hand was removed.At that time, the skin did not appear redness, swollen and bruised.At 21:00, there was slight redness and swelling on the left forearm, and at 00:00, there was a large area of redness and swelling.At 8:00 on august 15th, he took over a large area of bruising and redness.Immediately notify the doctor and report to the head nurse and department director, and apply magnesium sulfate damp heat.Potato chips were applied externally, closed with phentolamine and treated with oxygen, and the skin condition was closely observed.

Manufacturer Narrative

The following field was updated due to corrections: b.5.Describe event or problem: it was reported that the patient developed an edema with swelling and redness in the site the bd pegasus¿ safety closed iv catheter system was placed.As a result, damp, magnesium sulfate heat and potato chips were applied to the affected area, closed with phentolamine and treated with oxygen.H.6.Investigation summary: in response to the event reported, a device history review was conducted for lot number 2049649.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.Bd will continue to monitor this issue.

Event Description

It was reported that the patient developed an edema with swelling and redness in the site the bd pegasus¿ safety closed iv catheter system was placed.As a result, damp, magnesium sulfate heat and potato chips were applied to the affected area, closed with phentolamine and treated with oxygen.The following information was provided by the initial reporter, translated from chinese: "the patient's blood pressure was low at 03:47, 66/35mmhg.Notify the doctor and follow the doctor's instructions to speed up the infusion rate.At 04:19, he was given gs50ml + nor 8mg, micropumped at 3ml/h, and the vein was reset at 06:00 on august 14th.The indwelling needle was placed on the back of the left hand, the nail pump was continuously removed, and the pump was micro-pumped at 4ml/h, and the blood returned smoothly after the shift at 8:00.Close observation.Edema appeared in the left arm, and the intravenous indwelling needle was re-inserted at 16:00, and the indwelling needle on the back of the left hand was removed.At that time, the skin did not appear redness, swollen and bruised.At 21:00, there was slight redness and swelling on the left forearm, and at 00:00, there was a large area of redness and swelling.At 8:00 on august 15th, he took over a large area of bruising and redness.Immediately notify the doctor and report to the head nurse and department director, and apply magnesium sulfate damp heat.Potato chips were applied externally, closed with phentolamine and treated with oxygen, and the skin condition was closely observed.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15926906
• MDR Text Key: 304956601
• Report Number: 3014704491-2022-00638
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903839124
• UDI-Public: (01)00382903839124
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 383912
• Device Lot Number: 2049649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention