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

Catalog Number 400722

Device Problem Leak/Splash (1354)

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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

It was reported that 12 of the anesthesia kit perisafe vi cal experienced leakage.The following information was provided by the initial reporter, translated from spanish to english: at the time of the review we found 12 damaged pieces with the burst iodine envelope, in some pieces they are only drops that are appreciated and in others the damage is greater.

Manufacturer Narrative

H3.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 12 of the anesthesia kit perisafe vi cal experienced leakage.The following information was provided by the initial reporter, translated from spanish to english: at the time of the review we found 12 damaged pieces with the burst iodine envelope, in some pieces they are only drops that are appreciated and in others the damage is greater.

Manufacturer Narrative

H6: investigation summary during the process of getting the samples to our manufacturing facility, an issue occurred when attempting to send the samples across the us mexico border, and they were not allowed to be sent to our manufacturing facility.Instead, additional photos of the samples were taken by bd personnel and were supplied to our manufacturing facility.Our quality engineer inspected the 9 photos provided by the customer and 11 additional photos taken by bd personnel for evaluation.The reported issue of leakage other was confirmed upon inspection of the sample photos.Analysis of the sample photos showed that there was spilled povidone iodine inside the packaging of the sample.Bd determined that the cause of the failure was likely associated to our supplier's manufacturing process.We have notified our supplier of the failure.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: ANESTHESIA KIT PERISAFE VI CAL
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17401276
• MDR Text Key: 320231137
• Report Number: 9610847-2023-00189
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400722
• Device Lot Number: 3062378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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