MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA; ARTERIAL CATHETER

Catalog Number 682245

Device Problem Complete Blockage (1094)

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

Event Date 12/18/2019

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 after insertion the catheter was discovered to be bent with a bd arterial cannula.The following information was provided by the initial reporter, translated from (b)(6) to english: after puncture and catheterization, the customer found the catheter was bent.Occurred qty: 1 time.

Manufacturer Narrative

H.6.Investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported that after insertion the catheter was discovered to be bent with a bd arterial cannula.The following information was provided by the initial reporter, translated from chinese to english: after puncture and catheterization, the customer found the catheter was bent.Occurred qty: 1 time.

• Brand Name: BD ARTERIAL CANNULA
• Type of Device: ARTERIAL CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9557888
• MDR Text Key: 180180381
• Report Number: 8041187-2019-01076
• Device Sequence Number: 1
• Product Code: FTN
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 682245
• Device Lot Number: 8196339
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other