MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANESTHESIA KIT DURASAFE 18X3-1/2; ANESTHESIA CONDUCTION KIT

Catalog Number 400714

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9304002.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Investigation conclusion: bd was not able to confirm the customer¿s indicated failure mode because there were no received photos or samples to perform an evaluation.Quality records have been consulted for tracking and trending purposes but issues like this are not detected which means pretty low occurrence.Process fmea rm4755, peura rm875 were reviewed there are proper controls in place to detect product malfunctions.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Root cause description: based on investigation results to date, root cause for manufacturing process cannot be determined.Rationale: based on an evaluation of severity and frequency it was determined that no corrective action is required at this time also the root cause was not identified, therefore, corrective and preventive actions were not implemented.

Event Description

It was reported that the anesthesia kit durasafe 18x3-1/2 leaked before use.This occurred on 9 separate occasions, but the dates are unknown.The following information was provided by the initial reporter, translated from spanish to english: "product presents spill.".

• Brand Name: ANESTHESIA KIT DURASAFE 18X3-1/2
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9772084
• MDR Text Key: 191695679
• Report Number: 9610847-2020-00065
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 400714
• Device Lot Number: 9304002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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 Outcome(s): Other