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

Catalog Number 383912

Device Problem Leak/Splash (1354)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/26/2022

Event Type  malfunction  

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 leaked during use.The following information was provided by the initial reporter, translated from chinese: "the nurse found liquid exudation at the tube of the indwelling needle when the puncture needle was venting air, so it was replaced immediately.".

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system leaked during use.The following information was provided by the initial reporter, translated from chinese: "the nurse found liquid exudation at the tube of the indwelling needle when the puncture needle was venting air, so it was replaced immediately.".

Manufacturer Narrative

A device history review was conducted for lot number 2018793.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.

• 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: 15353173
• MDR Text Key: 305875290
• Report Number: 3014704491-2022-00394
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 09/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383912
• Device Lot Number: 2018793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/25/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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