MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT

Catalog Number 401622

Device Problem Leak/Splash (1354)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

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 epidural catheter could not connect to the damaged bd durasafe¿ tray adapter during use. The following information was provided by the initial reporter, translated from (b)(6) to english: "the patient entered the operating room for normal anesthesia and puncture catheterization. After catheterization, it was found that the epidural catheter could not be connected to the connector, so he had to abandon this operation and replace the puncture kit for a second time. It does not cause the doctor's work extensively, and at the same time causes secondary injury to the patient, and also increases the risk of secondary injury and medical disputes".

• Brand Name: BD DURASAFE¿ TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12636835
• MDR Text Key: 281676740
• Report Number: 3014704491-2021-00199
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 401622
• Device Lot Number: 9232404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial