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

Model Number	400273
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11269637
• Report Number: 2243072-2021-00194
• Device Sequence Number: 14274397
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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 Expiration Date: 05/31/2025
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 0156895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60