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

Catalog Number 401622

Device Problem Material Separation (1562)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

It was reported that the bd durasafe¿ tray vinyl plugs were dislodged.The following was received from the initial reporter: the patient was sent to the operating room for circumferential mixed hemorrhoidectomy + lateral anal sphincterotomy for mixed hemorrhoids on (b)(6) 2023 at 15:15, requiring lumbar anesthesia prior to the procedure, and disinfecting and spreading the towel as per routine, and checking the syringes for drug draws revealed that the vinyl plugs of the 2ml syringes were dislodged and could not be used.The 2ml syringe was replaced with a new one.

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6).H3.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 the bd durasafe¿ tray vinyl plugs were dislodged.The following was received from the initial reporter: the patient was sent to the operating room for circumferential mixed hemorrhoidectomy + lateral anal sphincterotomy for mixed hemorrhoids on july 25, 2023 at 15:15, requiring lumbar anesthesia prior to the procedure, and disinfecting and spreading the towel as per routine, and checking the syringes for drug draws revealed that the vinyl plugs of the 2ml syringes were dislodged and could not be used.The 2ml syringe was replaced with a new one.

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 2222433.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, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17507348
• MDR Text Key: 321636051
• Report Number: 3014704491-2023-00442
• 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,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401622
• Device Lot Number: 2222433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 10/01/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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