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 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2347356.D.4.Medical device expiration date: 06-jan-2028.H.4.Device manufacture date: 13-dec-2022.D.4.Medical device lot #: 3003861.D.4.Medical device expiration date: 13-feb-2028.H.4.Device manufacture date: 03-jan-2023.H.3.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 a bd durasafe¿ tray each from lots 2347356 and 3003861 had blocked needles.The following information was provided by the initial reporter, translated from chinese: "for the sacks with batch number 3003861,3003869,2347356, according to the feedback of xxxxx, during the use process: the needles of the sacks were found to be blocked and there were foreign bodies, which could not be used.".

Event Description

For the sacks with batch number 3003861,3003869,2347356, according to the feedback of [(b)(6) hospital, during the use process: the needles of the sacks were found to be blocked and there were foreign bodies, which could not be used.The customer expects to receive samples with 1:1 compensation.

Manufacturer Narrative

1.No defective sample were returned, and no defective photo were returned from the customer, root cause cannot be confirmed.2.Review batch record information: 1) the complaint batch number lot#2347356 is packaged in as packaging line, the production date is 2023-01, and the batch quantity is (b)(4).2) check the in-process inspection and shipment inspection report of this batch of products.The test results meet the product standards and there is no abnormality.3) check the production records and machine maintenance of this batch of products, and there are no abnormalities, deviations or rework activities.3.Due to customer did not specify the detail needle was clogged, plant cannot confirm which needle is defected.So, plant tested all the needle of retained sample: spinal needle, epidural needle, puncture needles, all the test result are pass, no abnormality was observed, no clogged, and no fm was observed,attachment1 -the needle of retained sample, attachment2- the test of retained sample.4.Due to no defective sample was returned, the defect mode cannot be identified, the root cause cannot be confirmed.5.The plant continue pay attention to this defect.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17831122
• MDR Text Key: 324453224
• Report Number: 3014704491-2023-00604
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 3003861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• 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