MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL NEEDLE KIT: 17 GA. X 3-1/2"; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05500-KPR1

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2019

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 there is a standing issue over the last few months orders where the kits have broken ampules or broken syringes.

Event Description

It was reported there is a standing issue over the last few months orders where the kits have broken ampules or broken syringes.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nc to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.Complaint verification testing could not be performed as no sample was returned for analysis.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 capa was initiated to further investigate this complaint issue.

• Brand Name: EPIDURAL NEEDLE KIT: 17 GA. X 3-1/2"
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8728697
• MDR Text Key: 149003638
• Report Number: 1036844-2019-00693
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K884552
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: ASK-05500-KPR1
• Device Lot Number: 23F18M0283
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1