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

Catalog Number 401622

Device Problem Complete Blockage (1094)

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

Event Date 06/25/2019

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 an unspecified number of anesthesia 17ga x 18cm durasafes experienced a clogged/blocked needle which was noted after use.The following information was provided by the initial reporter: after the anesthesiologist punctured the tube for the patient's epidural, he found that the epidural catheter was blocked and could not be administered, only to replace the new anaesthetic wear bag, re-pierce the puncture tube, and cause unnecessary trouble to the work and the patient.

Manufacturer Narrative

This complaint has been identified as a duplicate of mfr report #(b)(4) and should therefore be disregarded.This incident and any additional information relevant to it will be found under mfr report # (b)(4).H3 other text : see h.10.

Event Description

It was reported that an unspecified number of anesthesia 17gax18cm durasafes experienced a clogged/blocked needle which was noted after use.The following information was provided by the initial reporter: after the anesthesiologist punctured the tube for the patient's epidural, he found that the epidural catheter was blocked and could not be administered, only to replace the new anaesthetic wear bag, re-pierce the puncture tube, and cause unnecessary trouble to the work and the patient.

• Brand Name: ANESTHESIA 17GAX18CM DURASAFE
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 8921614
• MDR Text Key: 155529087
• Report Number: 3006948883-2019-00684
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 401622
• Device Lot Number: 8323608
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other