MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) US CATHENA 22GX1.00IN WINGED BC; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	386881
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that us cathena 22gx1.00in winged bc had a safety mechanism failure.The following information was provided by the initial reporter: material no.: 386881 batch no.: unknown.It was reported that the 22g 1" cathena catheter safety did not engage when off of catheter.Verbatim: customer unsure if she forced the white part off of catheter hub prior to safety or if it freely came off.She was able to safety after detached from catheter.
Event or Problem Description
It was reported that us cathena 22gx1.00in winged bc had a safety mechanism failure.The following information was provided by the initial reporter: material no.: 386881 batch no.: unknown it was reported that the 22g 1" cathena catheter safety did not engage when off of catheter.Verbatim: customer unsure if she forced the white part off of catheter hub prior to safety or if it freely came off.She was able to safety after detached from catheter.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.

• Brand Name: US CATHENA 22GX1.00IN WINGED BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11682137
• Report Number: 8041187-2021-00303
• Device Sequence Number: 3520560
• Product Code: FOZ
• UDI-Device Identifier: 00382903868810
• UDI-Public: 00382903868810
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 386881
• Device Catalogue Number: 386881
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1