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 07/20/2020

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 leakage was found coming from the bd durasafe¿ tray unit packaging after unpacking it.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.".

Event Description

It was reported that leakage was found coming from the bd durasafe¿ tray unit packaging after unpacking it.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 eval yes, d10: returned to manufacturer on: 05-nov-2022.H6: investigation summary: a device history review was conducted for lot number 9102592.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 a tear in the packaging bag, and an intact seal along the intended tearing position.The issue has been confirmed.Closer analysis of the bag was able to identify characteristic markings on the bag that indicate that an external force was applied to the packaging sometime after manufacturing.Based on this observation our engineers were not able to associate the root cause for this event this event with the packaging process.H3 other text : see h10.

• 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: 15670721
• MDR Text Key: 306796622
• Report Number: 3014704491-2022-00520
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 9102592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2019
• 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