MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 24GX0.75IN STRAIGHT BC; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	386807
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
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 cathena 24gx0.75in straight bc safety mechanism needle tip was uncovered.The following information was provided by the initial reporter: after placing and advancing the catheter, the hcp activated the safety mechanism but the needle tip was uncovered by the safety shield.
Event or Problem Description
It was reported that cathena 24gx0.75in straight bc safety mechanism needle tip was uncovered.The following information was provided by the initial reporter: after placing and advancing the catheter, the hcp activated the safety mechanism but the needle tip was uncovered by the safety shield.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/19/2021.H.6.Investigation: three photos and one sample without packaging was received by our quality team for evaluation.From the photos, it was observed that the safety mechanism was not activated and there is blood at the needle hub flashback chamber.Further inspection of the sample found 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 could not be evaluated as the lot number is unknown.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h.10.

• Brand Name: CATHENA 24GX0.75IN STRAIGHT BC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11744404
• Report Number: 8041187-2021-00360
• Device Sequence Number: 4417839
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/26/2021

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: 386807
• Device Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1