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	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd cathena¿ safety iv catheter exhibited retraction failure.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: 1 actual sample was returned for investigation.The returned sample was tested for safety activation and checked for retraction failure after the activation.Retraction failure was observed.The adapter failed to separate from the tip shield after the safety activation.It was found that the orientation of the catheter adapter is wrong.Dhr was reviewed and no quality notifications were raised for similar nonconformance during the production of this batch.Investigation conclusion: the root cause of the non-conformance is due to improper assembly.It was observed that catheter adapter was assembled into the tip shield in the wrong orientation.Therefore the adapter failed to separate from the tip shield after the safety activation.
Event or Problem Description
It was reported that bd cathena¿ safety iv catheter exhibited retraction failure.No serious injury or medical intervention was reported.

• 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: 7857513
• Report Number: 8041187-2018-00306
• Device Sequence Number: 16436850
• 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): 10/24/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 08/18/2018
• Supplement Date Received by Manufacturer: 08/18/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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