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

Catalog Number 401622

Device Problem Packaging Problem (3007)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: unknown.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 3 bd durasafe¿ trays leaked from their packaging before use after unpacking them.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, the package leaked after unpacking and could not be used.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation: yes.D10: returned to manufacturer on: 04-nov-2022.H6: investigation summary: a device history review was conducted for lot number 2012382.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, samples have been received by our facility for this complaint.Our engineers have reviewed the returned units and found the packaging to be undamaged, the seals intact, and the application of glue adequate and within product specifications.Unfortunately, without the ability observe the reported non-conformance our engineers could not determine a root cause for this event.H3 other text: see h10.

Event Description

It was reported that 3 bd durasafe¿ trays leaked from their packaging before use after unpacking them.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, the package leaked after unpacking and could not be 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: 15660129
• MDR Text Key: 306991257
• Report Number: 3014704491-2022-00510
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 2012382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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