MAUDE Adverse Event Report: BD (SUZHOU) BD DURASAFE¿ TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 401622

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that the bd durasafe¿ tray's packaging was damaged and leaking.The following was translated from chinese to english: (b)(6) 2023 the patient entered the operating room for normal anesthesia and puncture, and the puncture process was smooth.After puncture, when the placenta was packed in the anesthesia puncture bag, it was found that the bag was leaking.Therefore, the aseptic tightness of the anesthesia puncture kit cannot be guaranteed, which means that the patient is at risk of infection of the puncture site or central nervous system.

Manufacturer Narrative

(b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 3003872.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.

Event Description

It was reported that the bd durasafe¿ tray's packaging was damaged and leaking.The following was translated from chinese to english: (b)(6) 2023 the patient entered the operating room for normal anesthesia and puncture, and the puncture process was smooth.After puncture, when the placenta was packed in the anesthesia puncture bag, it was found that the bag was leaking.Therefore, the aseptic tightness of the anesthesia puncture kit cannot be guaranteed, which means that the patient is at risk of infection of the puncture site or central nervous system.

• Brand Name: BD DURASAFE¿ TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17808025
• MDR Text Key: 324147185
• Report Number: 3014704491-2023-00592
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401622
• Device Lot Number: 3003872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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