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 03/31/2020

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

The report states: anesthesia technician notified me this morning of reports from the ob director of 2 kits from same lot with broken vials.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed based on potential lot numbers (23f19d0087 and 23f19d0007) provided by the customer.Lot number 23f19d0087 is for kit cdc-45703-xp1a so the device history record review was performed for lot number 23f19d0007.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 based on a potential lot number provided by the customer.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.

Event Description

The report states: anesthesia technician notified me this morning of reports from the ob director of 2 kits from same lot with broken vials.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9936501
• MDR Text Key: 186866561
• Report Number: 1036844-2020-00137
• 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: 03/31/2020

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 Catalogue Number: AM-05501
• Device Lot Number: 23F19D0087
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1