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

Catalog Number 401622

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9319727, medical device expiration date: 2024-11-10, device manufacture date: 2019-11-15.Medical device lot #: 9319733, medical device expiration date: 2024-11-22, device manufacture date: 2019-11-15.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the outer box of bd durasafe¿ trays had a modified batch number on it.This affected 10 trays from lot 9319727, and 11 trays from lot 9319733.The following information was provided by the initial reporter, translated from chinese to english: "when receiving the goods, their three-party warehouse found that the batch number on the outer box had been modified".

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot numbers 9319727 & 9319733.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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the outer box of bd durasafe¿ trays had a modified batch number on it.This affected 10 trays from lot 9319727, and 11 trays from lot 9319733.The following information was provided by the initial reporter, translated from chinese to english: "when receiving the goods, their three-party warehouse found that the batch number on the outer box had been modified.".

Event Description

It was reported that the outer box of bd durasafe¿ trays had a modified batch number on it.This affected 10 trays from lot 9319727, and 11 trays from lot 9319733.The following information was provided by the initial reporter, translated from chinese to english: "when receiving the goods, their three-party warehouse found that the batch number on the outer box had been modified".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot numbers 9319727 & 9319733.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.Based on the photograph provided to our engineers, they were able to identify this as an issue of variance during ink stamping of the batch number on to the master case.Such defects may be caused by the depth of the ink color of the seal.There is no abnormality in the product information visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.H3 other text : see h.10.

• Brand Name: BD DURASAFE¿ TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10860810
• MDR Text Key: 226089096
• Report Number: 3006948883-2020-00788
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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