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	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8060125, medical device expiration date: 2021-03-31, device manufacture date: 2018-03-01.Medical device lot #: 8029209, medical device expiration date: 2021-01-31, device manufacture date: 2018-01-29.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.
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: nine (9) representative samples in sealed package were returned for investigation.Six (6) representative samples are from (b)(4) and 3 representative samples are from (b)(4).All returned samples was tested for safety activation and checked for retraction failure after the activation.No retraction failure was observed after safety activation.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: the root cause cannot be determined as no retraction failure was observed after safety activation.The nonconformance cannot be confirmed.

• 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: 7857485
• Report Number: 8041187-2018-00305
• Device Sequence Number: 11188224
• 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): 10/08/2018

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 Catalogue Number: 386801
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• 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: 10/10/2018
• 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