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

Catalog Number 401622

Device Problem Complete Blockage (1094)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that the bd durasafe¿ tray needle was blocked during use.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, it was found that the blocked tube could not be used in the process of use, and it was found that it could not be clamped and used".

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.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.H6: investigation summary a device history review was conducted for lot number 1070521.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.Additionally, three samples have been received by our facility for this complaint.Our engineers have subjected the returned device to functional testing for flow rate.Only one device was a found to be clogged.The issue has been confirmed.Closer inspection of the affected unit was able to locate a dried medicinal liquid blocking the flow channel.After removing this material the device was retested for flow rate conformance and was found to be free of any additional obstructions.Based on the results our engineers believe the root cause for this event is related to the interaction of the medical solution being infused into the patient.

Event Description

It was reported that the bd durasafe¿ tray needle was blocked during use.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, it was found that the blocked tube could not be used in the process of use, and it was found that it could not be clamped and used.".

• 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: 15678836
• MDR Text Key: 306606461
• Report Number: 3014704491-2022-00525
• 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: 11/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 1070521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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