MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER

Catalog Number 386801

Device Problem Device Slipped (1584)

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

Event Date 01/29/2019

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 with the use of the bd cathena¿ safety iv catheter there was an issue with silver metal bit flew out onto the prep area when the needle was removed.

Event Description

It was reported with the use of the bd cathena¿ safety iv catheter there was an issue with silver metal bit flew out onto the prep area when the needle was removed.

Manufacturer Narrative

Investigation summary: a device history record review was performed and showed no non-conformances associated with this issue during the production of this batch 1 photo was received for investigation.It was observed that the shield has detached from the cannula and the washer has fell out of the shield.The complaint is confirmed and product is not within the specification.1 representative sample was returned in unopened package.The sample was subjected to safety activation test.It passed the activation test; no abnormality was observed.1 actual sample was received without the washer and cannula, only a detached shield.The sample was not decontaminated.No damage or abnormally was observed on the detached shield.Further investigation could not be carried out as the washer and cannula were not returned for investigation.Hence, the root cause could not be determined.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8348680
• MDR Text Key: 136768754
• Report Number: 8041187-2019-00158
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 386801
• Device Lot Number: 8060125
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other