MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA NEEDLE

Catalog Number 401622

Device Problem Leak/Splash (1354)

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

Event Date 10/28/2019

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 the anesthesia 17gax18cm durasafe experienced product damage/deformation with the device still considered operable.The product defect was noted during use.The following information was provided by the initial reporter: when the product was using, the fluid in the front tube didn't flow.

Event Description

It was reported that the anesthesia 17gax18cm durasafe experienced product damage/deformation with the device still considered operable.The product defect was noted during use.The following information was provided by the initial reporter: when the product was using, the fluid in the front tube didn't flow.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8304708.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.Additionally, occlusion testing of the submitted device found that the unit was free of any obstructions and operating as intended.Unfortunately without the ability to observe the reported failure mode, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: ANESTHESIA 17GAX18CM DURASAFE
• Type of Device: ANESTHESIA NEEDLE
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9311773
• MDR Text Key: 180202093
• Report Number: 3006948883-2019-00943
• Device Sequence Number: 1
• Product Code: BSP
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/21/2023
• Device Catalogue Number: 401622
• Device Lot Number: 8304708
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other