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 Problem Leak/Splash (1354)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that 6 bd durasafe¿ anesthesia kits had leaked povidone-iodine envelopes.The following information was provided by the initial reporter, translated from spanish: "at the time of the review in one of the cases, they found 6 damaged pieces, which came with the povidone-iodine envelope showing leaks.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: unknown.Initial reporter e-mail: unknown.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 6 bd durasafe¿ anesthesia kits had leaking povidone-iodine envelopes.The following information was provided by the initial reporter, translated from spanish: "at the time of the review in one of the cases, they found 6 damaged pieces, which came with the povidone-iodine envelope showing leaks.".

Manufacturer Narrative

Investigation summary: our quality engineer inspected the 6 photos submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr for this lot was reviewed and there are 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.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15753975
• MDR Text Key: 305727443
• Report Number: 9610847-2022-00420
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904007140
• UDI-Public: (01)00382904007140
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: K012584
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400714
• Device Lot Number: 2208295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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