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

Catalog Number	386883
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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 us cathena 20gx1.00in winged bc needle through catheter it was reported by customer that when retracting the needle it is piercing through the catheter.This should be able to be inserted and retracted without the needle causing damage to the catheter.Rcc received a complaint via email.20 gauge.Lot # 4005488 - 2 boxes of 30, 60 total, 9 used, 51 left.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the photos.The defect may be related to reinsertion of the needle into the catheter.However, as it is not possible to confirm how the product was being handled, a definitive root cause cannot be determined.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.

• Brand Name: BD US 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: 22828097
• Report Number: 2243072-2025-01011
• Device Sequence Number: 11903302
• Product Code: FOZ
• UDI-Device Identifier: 00382903868834
• UDI-Public: (01)00382903868834(17)261231(10)4005488
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2025

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: 386883
• Device Lot Number: 4005488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 10/09/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown