MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386806
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 22gx1.00in straight bc catheter was defective / damaged it was reported by the customer that catheter used on a patient has an end that appears frayed.They questioned the safety of this catheter, as a small piece of material could come off and be dangerous for the patient.Verbatim: a nurse in the endoscopy department in the recovery room reports that a catheter used on a patient has an end that appears frayed.He questioned the safety of this catheter, as a small piece of material could come off and be dangerous for the patient.The catheter is being kept.
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 submitted for evaluation.The reported issue of catheter defective/ damaged was not confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.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.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed no damage on the catheter tip.There was excess silicone on the catheter tip.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The assembly process of the cannula lubrication process was reviewed.The cannula is lubricated by dipping it into a silicone lube tank.During dipping, low air flow is blown through the cannula to prevent silicone flowing into the cannula.After dipping, the part is raised from the silicone lube tank followed by high pressure air blown through the cannula to remove the excess silicone.The catheter subassemblies are then set together with the needle hub subassembly.The assembled part then goes through a series of processes and loaded with the needle cover.There could have been silicone accumulated at the surface of the lube tank which might have transferred to the cannula surface during air blowing.After the catheter subassemblies are set together with the needle hub subassembly, given the silicone-like nature of the lube it is possible for the excess silicone to migrate to the cannula/catheter tip area during transportation or storage.To prevent this defect, revision of the procedure will be completed to include cleaning of the surface of the lube tank and surrounding areas every shift.

• Brand Name: CATHENA
• 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: 22693118
• Report Number: 2243072-2025-00944
• Device Sequence Number: 8250883
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063(11)241102(17)271031(10)4304898
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/29/2025

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: 4304898
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 08/29/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown