MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 22GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386806
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 22gx1.00in straight bc needle went through the catheter phone call received form xxxx regarding another incident with cathena ivcs, this time a 22g.Reported that a 22g cathena was placed into a patient's arm in dosa department and that the clinician had difficulty advancing the ivc into the patient- said "felt stuck".Upon removal (as could not use), discovered the needle was poking through the side of the cathena.Patient required new insertion of cathena ivc, no delay to treatment.Xxxxx reported initially that the sticktion was not released by loosening the ivc, but later called to informed that they did and that she believes is user error.Sample retained and available for collection.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and samples submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the samples.Analysis of the samples showed the needle had pierced through the catheter.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 assembly process was reviewed.If the needle pierced through the catheter during the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needles can pierce through the catheter during product application, when the product was manipulated, or during needle cover removal if not done carefully.Current control is an in-process inspection in place to check for needles that have pierced through the catheter.
Additional Manufacturer Narrative
Correction to lot number.Batch number 4310711 was entered incorrectly; the correct batch number is 4310771.

• Brand Name: BD CATHENA 22GX1.00IN STRAIGHT 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: 21911074
• Report Number: 2243072-2025-00574
• Device Sequence Number: 9099449
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2025

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: 386806
• Device Lot Number: 4310711
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 12/10/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/22/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown