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

Catalog Number 401622

Device Problem Defective Device (2588)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd durasafe¿ tray the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the nurse in the anesthesiology department reported that when using a 3ml syringe to draw medicine, the rubber stopper was found to be defective.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 10jul2023.H6: investigation summary in response to the event reported by your facility a device history review was conducted for lot number 2222446.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.Additionlaly a smaple has been provided to aid in our investigaiton.Our enigneers have reviewed the device and determine the primary cause fo this issue to be directly related to the raw material purchased form the supplier.H3 other text : see h.10.

Event Description

It was reported while using bd durasafe¿ tray the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the nurse in the anesthesiology department reported that when using a 3ml syringe to draw medicine, the rubber stopper was found to be defective.

• 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 ; 8448235433
• MDR Report Key: 17312957
• MDR Text Key: 319248695
• Report Number: 3014704491-2023-00344
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 2222446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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