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

Catalog Number 401622

Device Problem Defective Component (2292)

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

Event Date 10/16/2022

Event Type  malfunction  

Manufacturer Narrative

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 the syringe in the bd durasafe¿ tray was not sealed, resulting in inaccurate positioning while testing puncture depth.The following information was provided by the initial reporter, translated from chinese: "it was reported to the purchasing department that the pressure syringe in the bd puncture bag was not sealed during the cesarean section and spinal anesthesia, resulting in the inability to accurately locate the puncture depth when testing.Because it was inconsistent with the operating experience, the chief anesthesiologist and department leaders discovered the problem in time.And corrections were made.No adverse consequences were caused.During neuraxial anaesthesia for cesarean section, the pressure syringe in the puncture bag was not sealed, resulting in inaccurate positioning when testing the puncture depth.Because of the inconsistency with the operating experience, the main anesthesia doctor and department leaders found the problem in time and made corrections and remediation, without causing adverse consequences.".

Event Description

It was reported that the syringe in the bd durasafe¿ tray was not sealed, resulting in inaccurate positioning while testing puncture depth.The following information was provided by the initial reporter, translated from chinese: "it was reported to the purchasing department that the pressure syringe in the bd puncture bag was not sealed during the cesarean section and spinal anesthesia, resulting in the inability to accurately locate the puncture depth when testing.Because it was inconsistent with the operating experience, the chief anesthesiologist and department leaders discovered the problem in time.And corrections were made.No adverse consequences were caused.During neuraxial anaesthesia for cesarean section, the pressure syringe in the puncture bag was not sealed, resulting in inaccurate positioning when testing the puncture depth.Because of the inconsistency with the operating experience, the main anesthesia doctor and department leaders found the problem in time and made corrections and remediation, without causing adverse consequences.".

Manufacturer Narrative

Investigation summary a device history review was conducted for lot number 2102675.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, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15818046
• MDR Text Key: 307224821
• Report Number: 3014704491-2022-00574
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904016227
• UDI-Public: (01)00382904016227
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 2102675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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