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

Model Number	386811
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).
Event or Problem Description
It was reported that cathena 20gx1.25in winged bc had a retraction failure and caused a needle stick injury.The following information was provided by the initial reporter: during the installation of a vvp, the kt did not retract automatically when i wanted to remove it i pricked myself with the kt.
Additional Manufacturer Narrative
H.6.Investigation: 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.Batch number was unavailable and hence unable to perform the complaint history check.There is no increasing trend for the reported defect in the past 15 months.
Event or Problem Description
It was reported that cathena 20gx1.25in winged bc had a retraction failure and caused a needle stick injury.The following information was provided by the initial reporter: during the installation of a vvp, the kt did not retract automatically when i wanted to remove it i pricked myself with the kt.

• Brand Name: CATHENA 20GX1.25IN WINGED BC
• Common Device Name: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10824122
• Report Number: 8041187-2020-00724
• Device Sequence Number: 3644999
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: 00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201717
• 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): 12/08/2020

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 Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 12/13/2020
• 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