MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386808
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
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 by customer that there appears to be some sort of substance noticed in the canula and protrudes from the tip of the canula when ensuring separation of canula and needle prior to use on patients.Some devices are not sharp enough to pierce skin.Complaint via email.Xxxxx mdip report incident or problem information xxxxx mdip reference number (id): (b)(4) date of incident (yyyy-mm-dd): (b)(6) 2026 type of incident/problem: a1.Defect (observed prior to use) level of harm: no effect - did not reach patient/person -- detected before use or does not touch patient before use xxxxx optional report to cmdsnet (health canada): incident details: there appears to be some sort of substance noticed in the canula and protrudes from the tip of the canula when ensuring separation of canula and needle prior to use on patients.Some devices are not sharp enough to pierce skin.Device information device name/description: catheter iv safety winged with multiguard 18gax1.25in cathena manufacturer: becton dickinson canada inc manufacturer code/model: 386808 serial or lot number: 4278305 supplier: xxxxx supplier/catalogue number: 333-386808 is the device retained?.
Additional Manufacturer Narrative
Our quality engineer inspected the 4 samples submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the samples.Analysis of the samples showed no foreign matter; however, visible silicone was observed on 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 have been reviewed, and this batch meets our manufacturing specification requirements.The assembly process was reviewed.There could have been silicone accumulated at the surface of the lube tank which might have transferred to the cannula surface.After catheter subassemblies are set together with the needle hub subassembly, it is possible for the silicone to migrate to the cannula/catheter tip area during transportation or storage.The cleaning form was updated to include cleaning the surface area of the lube tank and surrounding areas every shift.The reported lot number was manufactured before action implementation.

• 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: 25017437
• Report Number: 2243072-2026-00315
• Device Sequence Number: 9587904
• Product Code: FOZ
• UDI-Device Identifier: 00382903868087
• UDI-Public: (01)00382903868087(10)4278305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 386808
• Device Lot Number: 4278305
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown