MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386801
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
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 18gx1.25in straight bc had foreign matter cathena cannula with substance inside tip of device.On retraction of stylet, customer noticed visible substance on inside of cannula near tip of device.
Additional Manufacturer Narrative
Our quality engineer inspected the two samples submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the samples.Analysis of the samples showed no damage on the catheter tip.Foreign matter was observed on the cannula tip and covers.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.Based on similar (b)(4), visible silicone was observed on the cannula, catheter and catheter body under 10x microscope.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: 22459392
• Report Number: 2243072-2025-00838
• Device Sequence Number: 12910872
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: (01)00382903868018(11)241102(17)271031(10)4304881
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 386801
• Device Lot Number: 4304881
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/04/2025
• 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