MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383714

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 04/10/2019

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 during use of the bd pegasus¿ safety closed iv catheter system the flow was occluded.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: event date: (b)(6) 2019.The nurse found that the extension tubing leaked at the luer connection during flushing after penetration.The catheter was removed and replaced.The new catheter worked normally.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8256300.Our records show that this is the 6th 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.Only a photo was provided for the investigation for this failure mode, based off the photo and history investigation information for this related defect, the possible root cause is process related.The flaring process is when the metal wedge crashes the support platform/ supporting gripper and causes the metal wedge to have damage.The damaged metal wedge scratches the extension tubing and causes the leaking issue.The manufacturing site has taken corrective actions to prevent this failure mode from occurring such as checking the alignment and cam angle in weekly maintenance occurrences and making machine repairs once any damage is found.

Event Description

It was reported that during use of the bd pegasus¿ safety closed iv catheter system the flow was occluded.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: event date: (b)(6)2019.The nurse found that the extension tubing leaked at the luer connection during flushing after penetration.The catheter was removed and replaced.The new catheter worked normally.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8586979
• MDR Text Key: 145114623
• Report Number: 8041187-2019-00351
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 383714
• Device Lot Number: 8256300
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other