MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10; INTERVASCULAR CATHETER

Catalog Number 383734

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap) 22ga x 1.00in 0.9mm x 25mm.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap) 22ga x 1.00in 0.9mm x 25mm experienced leakage at adapter and tubing.The following information was provided by the initial reporter: leakage was found at the end of the extension tube before injection.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 0197307.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 h.10.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap) 22ga x 1.00in 0.9mm x 25mm experienced leakage at adapter and tubing.The following information was provided by the initial reporter: leakage was found at the end of the extension tube before injection.

• Brand Name: SEE H10
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11061683
• MDR Text Key: 223458630
• Report Number: 8041187-2020-00863
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 383734
• Device Lot Number: 0197307
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1