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

Catalog Number 401622

Device Problems Complete Blockage (1094); Leak/Splash (1354)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 during use the needle was clogged with a bd anesthesia 17gax18cm durasafe¿.The following information was provided by the initial reporter, translated from (b)(6) to english: the drug encountered resistance when injected into the patient and could not be injected.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9017599.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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.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 during use the needle was clogged with a bd anesthesia 17gax18cm durasafe¿.The following information was provided by the initial reporter, translated from chinese to english: the drug encountered resistance when injected into the patient and could not be injected.

• Brand Name: BD ANESTHESIA 17GAX18CM DURASAFE¿
• Type of Device: ANESTHESIA KIT
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9474972
• MDR Text Key: 180622761
• Report Number: 3006948883-2019-01093
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/26/2024
• Device Catalogue Number: 401622
• Device Lot Number: 9017599
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other