MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX1.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386810
Medical Device Problem Codes	Retraction Problem (1536); Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd cathena 20gx1.00in winged bc needle shielding failed.Date of occurrence: (b)(6) 2025.Reference: 386810.Batch number: 4180596.Description of defect: during the insertion of a peripheral venous line with the secure winged catheter, a nurse pricked herself due to a securing release fault.In addition, the patient had sepsis caused by highly resistant bacteria.The nurse was treated as an emergency according to the blood exposure accident (bea) protocol.The defective medical device was retained.Would you like the case to be returned for expert appraisal?.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and three samples submitted for evaluation.The reported issue of needle shielding failure was not confirmed upon inspection of the sample.Analysis of the samples showed no damages or defects.The samples were subjected to an activation test and all samples passed with no abnormalities observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.

• Brand Name: BD CATHENA 20GX1.00IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21969394
• Report Number: 2243072-2025-00620
• Device Sequence Number: 20868437
• Product Code: FOZ
• UDI-Device Identifier: 00382903868100
• UDI-Public: (01)00382903868100(11)240702(17)270630(10)4180596
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: Health Professional
• Device Catalogue Number: 386810
• Device Lot Number: 4180596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown