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

Model Number 386811

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 10/16/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10824122
• MDR Text Key: 216416368
• Report Number: 8041187-2020-00724
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: 00382903868117
• Combination Product (y/n): N
• PMA/PMN Number: K201717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other