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

Catalog Number	400273
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
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
Description: while inserting catheter kinked.No patient harm.
Additional Manufacturer Narrative
Investigation results: one photo was received by our quality team for evaluation.Based on the photo, it was observed that the catheter was kinked; therefore, the reported incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Based on our quality team's investigation, the potential root cause could be related to handling issues.As explained in the ifu, to avoid damaging the catheter, do not withdraw it through the needle once it has passed beyond the epidural needle tip.Secure the catheter aseptically at the puncture site with sufficient slack to prevent pull-out and kinking.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• 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: 21689247
• Report Number: 2618282-2025-00027
• Device Sequence Number: 12944304
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732(11)230510(17)280331(10)3089736
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 400273
• Device Lot Number: 3089736
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown