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

Catalog Number 383718

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/02/2019

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 with q-syte¿ leaked blood past the septum during use after the penetration.The following information was provided by the initial reporter, translated from (b)(6) to english: "after completed penetration, it's noticed that blood leakage at the septum".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 7048344.Our records show that this is the second 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 was submitted for evaluation and testing.No abnormalities could be identified in the returned sample despite attempts to identify the cause using leakage testing and microscopic evaluation of the device.Based on our results, the root cause for this complaint could not be associated with the manufacturing process at the conclusion of our review; bd apologizes for any inconvenience your facility may have experienced as a result of this event and will continue to track and trend for this issue.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system with q-syte¿ leaked blood past the septum during use after the penetration.The following information was provided by the initial reporter, translated from chinese to english: "after completed penetration, it's noticed that blood leakage at the septum".

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WITH Q-SYTE¿
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9483302
• MDR Text Key: 181438151
• Report Number: 3006948883-2019-01101
• 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: 01/06/2020

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: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 383718
• Device Lot Number: 7048344
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other