MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05503-UPM

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2019

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 when opening the kit, they noticed the lidocaine bottle was broken in 5 random kits but all having same lot 23f19g0146.

Event Description

It was reported that when opening the kit, they noticed the lidocaine bottle was broken in 5 random kits but all having same lot 23f19g0146.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural kit with no relevant findings.The customer reported broken ampules in the kit.The customer returned one opened kit which contained the lidocaine ampule broken into two pieces for investigation (reference files (b)(4)).The ampule was visually examined with and without magnification.Visual examination of the ampule revealed the ampule is broken at the score line.No pieces of the ampule appear to be missing.No other defects or anomalies were observed (reference files (b)(4)).The reported complaint of a broken ampule was confirmed based upon the sample received.The lidocaine ampule was found to have broken at the score line.A device history record review was performed with no relevant findings.Based on the information provided, the potential root cause of this issue is design related.A capa was initiated to further investigate this complaint issue.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA X 35
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9311748
• MDR Text Key: 180212389
• Report Number: 1036844-2019-01056
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: ASK-05503-UPM
• Device Lot Number: 23F19G0146
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1