MAUDE Adverse Event Report: TELEFLEX MEDICAL SPINAL ANESTHESIA KIT; NEEDLE, CONDUCTION, ANESTHETIC

Catalog Number AK-05503-L

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the glass vials of medication were broken.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the kit and the ampules with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the kit and ampules with no evidence to suggest a manufacturing related cause.The potential cause of the broken ampules could not be determined based upon the information provided and without a sample.

Event Description

It was reported that the glass vials of medication were broken.

• Brand Name: SPINAL ANESTHESIA KIT
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10822552
• MDR Text Key: 215918641
• Report Number: 1036844-2020-00304
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K911260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: AK-05503-L
• Device Lot Number: 23F20H0296
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1