MAUDE Adverse Event Report: BD (SUZHOU) ANESTHESIA 17GAX18CM DURASAFE; EPIDURAL KIT

Catalog Number 401622

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2019

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 before use of the anesthesia 17gax18cm durasafe there was an issue with foreign matter of a hair after opening the package.The following information was provided by the initial reporter, translated from (b)(6) to english: on october 29, 2019, rep.Received a complaint from the head nurse of the anesthesiology department.The material # 401622 anesthesia found suspected hair after opening the package.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 9348533.Our records show that this is the only instance of foreign matter 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 the photo submitted was reviewed by our quality engineers who determined that the foreign matter may be hair or fabric from the clothing of one of our operators.To prevent a reoccurrence of this event our facility has begun implementing one-piece clean room protective equipment, and will be discarding the split-style in use at the time of the production of this lot.

Event Description

It was reported that before use of the anesthesia 17gax18cm durasafe there was an issue with foreign matter of a hair after opening the package.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2019, rep.Received a complaint from the head nurse of the anesthesiology department.The material #: 401622 anesthesia found suspected hair after opening the package.

• Brand Name: ANESTHESIA 17GAX18CM DURASAFE
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9318317
• MDR Text Key: 180203148
• Report Number: 3006948883-2019-00948
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2023
• Device Catalogue Number: 401622
• Device Lot Number: 8348533
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other