MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD DURASAFE¿ ANESTHESIA KIT; ANESTHESIA CONDUCTION KIT

Catalog Number 400714

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd durasafe¿ anesthesia kit was found damaged and leaking before use.The following information was provided by the initial reporter, translated from spanish: "one damaged part of durasafe 400714, with lot 3031433.".

Manufacturer Narrative

H.6.Investigation summary: it was reported there was one damaged part in a durasafe kit.To aid in the investigation, one photo was provided for evaluation by our quality team.In the photo spilled povidone iodine is observed in the packaging.The defect was submitted to the supplier for evaluation.The cause was determined to be liquid in the seal that forms a channel and causes leaks.The supplier's logbook noted that there were issues with the pumps not being set correctly which may have caused the issue.A device history record review was completed for provided material number 400714, lot 3031433.The review revealed there were no internal rejects related to the reported issue by the customer.According to the quality records all the inspections of the sampling plan met the acceptance criteria.During manufacturing, the iodine is packaged along with the other components by operators.The units are inspected 100% for any damage or foreign materials.At the supplier, to prevent this issue going forward, pump logs will monitor all pump adjustments to prevent them from being set improperly.Machine checklists will be completed every shift while the machine is running to help detected if the machine is not properly set in a timely manner.Based on the investigation, bd was able to confirm the customer¿s indicated failure mode on the picture sample provided to the supplier but cannot confirm the defect to the bd manufacturing process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd durasafe¿ anesthesia kit was found damaged and leaking before use.The following information was provided by the initial reporter, translated from spanish: "one damaged part of durasafe 400714, with lot 3031433.".

• Brand Name: BD DURASAFE¿ ANESTHESIA KIT
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17410138
• MDR Text Key: 320036717
• Report Number: 9610847-2023-00192
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400714
• Device Lot Number: 3031433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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