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

Model Number 400273

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

One photo was received by our quality team for evaluation.Upon visual inspection, it was observed that there was a filter which is broken at the connection point.Photo showed inlet port completely broken at the base; therefore, the incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The root cause cannot be associated with the manufacturing process since no indications from the manufacturing records review of situations that could contribute to the customer reported failure.All inspections performed complied with inspections requirement and were found in accordance with bd specifications during incoming/packaging process inspection.(b)(4).

Event Description

It was reported that a kit perisafe 18ga 3-1/2in weiss leaked during use.The following was reported by the initial reporter: "initially, application had no complications.In the course of the operation, a puddle of fluid in the area of the filter of the epidural set has been noticed.Checked for any leaks by placing a dry cloth underneath.New formation of fluid has been observed.Inspection reveals fluid leakage in the area of the proximal luer lock at the connection to the filter.When the peridural catheter tube is rotated, the luerlock connection disconnects from the filter.".

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11269637
• MDR Text Key: 231307265
• Report Number: 2243072-2021-00194
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 0156895
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60