MAUDE Adverse Event Report: BECTON DICKINSON KIT PERISAFE 18GA 3-1/2IN WEISS-; ANESTHESIA CONDUCTION KIT

Catalog Number	400273
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It seemed as if there was only one hole open in the catheter, event details: received an epidural catheter during labor.In the delivery room, the pump indicates occlusion pressure after approximately 6 ml has been administered.This happens several times before i am called as an aps nurse.Visually, there is no kink in the pump tube or catheter.Because we use 3.00 m lines, occlusion pressure occasionally occurs.Therefore, a shorter pump tube (2.00 m) was connected, but without result.The syringe was then changed without result, the pump was changed without result, and the filter was replaced without result.The catheter was then withdrawn 2 cm, but that did not help either.Unfortunately, the epidural was considered ¿lost¿.After removing the epidural catheter, i received the catheter and examined it: there was no kink in the catheter anywhere.The catheter was connected to the pump (outside the patient) and the pump still gave an occlusion alarm.Flushing by hand was also almost impossible: it seemed as if there was only one hole open in the catheter: on the catheter, a few millimeters from the tip, only one drop came out of the catheter.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? change of filter to try solve the problem, no results.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
One catheter was received by our quality team for evaluation.The sample was submitted to the incoming area for inspection and tested for visual, dimensional, and functional characteristics.Dimensional testing confirmed that the catheter is within specification; however, the sample failed the functional test for occluded flow.Upon magnified inspection, it was observed that two out of the three holes show flash, which may be contributing to the occlusion.The reported incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause for this incident is related to the supplier manufacturing process as the catheter is supplied by an external supplier.Notification of this incident has been made to the supplier.This incident has been added to our database of reported incidents.

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS-
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22347241
• Report Number: 2618282-2025-00054
• Device Sequence Number: 11984146
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: NA
• 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): 09/12/2025

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: 400273
• Device Lot Number: UNKNOWN
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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