MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number AK-05560

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that each of the trays was found to have broken lidocaine ampules.There was no injury.

Event Description

It was reported that each of the trays was found to have broken lidocaine ampules.There was no injury.

Manufacturer Narrative

(b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was initiated to address broken ampule issues for lot# 23f18k0787.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.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.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 a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A nonconformance was initiated to further investigate this complaint issue.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8275263
• MDR Text Key: 134061819
• Report Number: 1036844-2019-00034
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: AK-05560
• Device Lot Number: 23F18K0787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1