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

Catalog Number 383914

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.Investigation summary: in response to the event reported a device history review was conducted for lot number 8106255.Our records show that this is the first instance of this issue occurring in this batch of bd pegasus.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.Unfortunately, a sample could not be obtained for evaluation and testing.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 and encourages you to submit your sample for review.Investigation conclusion: the gauge of the complaint batch is 24g.No abnormality found in the incoming material, the whole assemble process, packing process and sterilization process.Root cause description: because there was no complaint sample returned, we cannot confirm what cause this complaint.

Event Description

It was reported the connector was loose during usage of bd pegasus¿ safety closed iv catheter system.Prn connector was replaced.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8465545
• MDR Text Key: 141047301
• Report Number: 3006948883-2019-00225
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/06/2021
• Device Catalogue Number: 383914
• Device Lot Number: 8106255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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): Other