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

Catalog Number	386883
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
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 catheter was defective and leaked it was reported by customer that two catheters so far are defective.Both times blood has squirted out of the cannula that is supposed to be in the vein.They think there is a hole between the cannula and body of the catheter.These have zero blood stopping technology in addition to these so the bibs they use are saturated in blood.Rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no item: 386883 quantity affected: 2 bx serial/lot number: (b)(6) po : (b)(4).Are any samples available for return? yes reported issue: this studio is reporting two catheters so far are defective.Both times blood has squirted out of the cannula that is supposed to be in the vein.They think there is a hole between the cannula and body of the catheter.These have zero blood stopping technology in addition to these so, the bibs they use are saturated in blood.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 representative samples submitted for evaluation.The reported issue of leakage was not confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.Samples were subjected to a blood escape time and catheter leak test and all samples passed with no leakage 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.While the defect was not confirmed from the returned samples, previous investigations have confirmed a leak.Corrective actions have been initiated, and a manufacturing root cause has been identified for this failure mode.Actions have been made to address the issue.

• 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: 21753401
• Report Number: 2243072-2025-00425
• Device Sequence Number: 9647928
• Product Code: FOZ
• UDI-Device Identifier: 00382903868834
• UDI-Public: (01)00382903868834(11)240108(17)261231(10)4005488
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/01/2025
• 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