MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.25IN WINGED BC; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	386811
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 cathena 20gx1.25in winged bc had a safety mechanism failure.The following information was provided by the initial reporter: additional information (b)(6) 2021: there was no needle stick injury.Safety mechanism of the needle not activated, still unclear whether there has been a needlestick injury.Notification via email: after removing the iv needle from the cannula, the safety mechanism did not activate, on department emergency.
Event or Problem Description
It was reported that cathena 20gx1.25in winged bc had a safety mechanism failure.The following information was provided by the initial reporter: additional information (b)(6)2021: there was no needle stick injury.Safety mechanism of the needle not activated, still unclear whether there has been a needlestick injury.Notification via email: after removing the iv needle from the cannula, the safety mechanism did not activate, on department emergency!.
Additional Manufacturer Narrative
Investigation summary one sample in open packaging was received by our quality team for evaluation.The sample was observed with the safety mechanism not activated and no dented mark on the cannula.The tip shield was manually pushed through the cannula and was able to activate properly, no safety activation failure was observed.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: CATHENA 20GX1.25IN WINGED BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11742543
• Report Number: 8041187-2021-00356
• Device Sequence Number: 4417837
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: 00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Expiration Date: 02/28/2023
• Device Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: 0059312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1