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

Catalog Number 383718

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 blood leakage occurs at connection site with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: on the morning of (b)(6) 2019, patient start to use 24ga pegasus for infusion at 9 p.M.Of (b)(6) 2019, it's noticed that q-syte loosen from adapter and blood backs up blood leakage around 200 ml.

Event Description

It was reported that blood leakage occurs at connection site with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: on the morning of (b)(6) 2019, patient start to use 24ga pegasus for infusion at 9 p.M.Of (b)(6) 2019, it's noticed that q-syte loosen from adapter and blood backs up blood leakage around 200 ml.

Manufacturer Narrative

H.6.Investigation summary bd received samples from the customer facility for evaluation.A device history review was conducted for lot number 9106518.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 the submitted sample was subjected to torsion testing; the test results were unable to identify any abnormality in the connection between the qsyte and the adapter that could have lead to the reported non-conformance.Based on the test results, the root cause for this complaint could not be determined at the conclusion of our review.

• 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
• MDR Report Key: 9528031
• MDR Text Key: 180037997
• Report Number: 3006948883-2019-01134
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/23/2022
• Device Catalogue Number: 383718
• Device Lot Number: 9106518
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other