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

Catalog Number	386801
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8348680
• Report Number: 8041187-2019-00158
• Device Sequence Number: 1606587
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 386801
• Device Lot Number: 8060125
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other