MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number AM-05501

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2020

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 2 kits from same lot with broken vials.The reporter was unable to locate the kits at time of report.

Event Description

It was reported that 2 kits from same lot with broken vials.The reporter was unable to locate the kits at time of report.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the kit and ampules with a potentially relevant finding.For material # k-07900-001 (lidocaine w/epinephrine 5 ml), lot # 23p19l0082, according to incoming inspection records, 1 of 315 ampules were observed broken in a batch of 19200.This is outside of the parameter for this defect.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.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.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10014688
• MDR Text Key: 189570983
• Report Number: 1036844-2020-00140
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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: 05/31/2021
• Device Catalogue Number: AM-05501
• Device Lot Number: 23F19M0106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1