MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00820

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports when the catheter is uncovered, the guide is bent.The issue was noted prior to patient use.

Event Description

The customer reports when the catheter is uncovered, the guide is bent.The issue was noted prior to patient use.

Manufacturer Narrative

(b)(4).The customer returned an opened sac-00820 set containing a straight guide wire and a single lumen arterial catheter for evaluation.None of the components showed any obvious signs of use.The guide wire was returned in the catheter.Visual inspection revealed the guide wire had three kinks.In addition , the product packaging (chevron pouch) had several fold marks where it appeared the packaging had been folded over itself.The damage observed is consistent with defects related to shipping and handling of sac-00820 sets.The pouches this product is packaged in are long and folding the pouches over during shipping/handling/storage will cause the contents to bend and kink.Microscopic examination confirmed the kink and revealed both welds are full, intact, and spherical.The kinks in the guide wire were located 39, 55, and 66 mm from one of the guide wire welds.The length and outer diameter of the guide wire were measured and were found to be within specification.A device history record review was performed with no relevant findings.The reported complaint that the guide wire was found kinked prior to use was confirmed through visual inspection of the returned sample.The returned guide wire contained two kinks.In addition, the packaging contained damage as well.The damage to the packaging and guide wire are consistent with damage caused by shipping and handling of sac-00820 sets.Since this lot was manufactured, an engineering change order has been implemented to update the product labeling to clearly inform the customer to not bend the product and is intended to reduce the potential for product damage.A device history record review was performed and revealed no evidence to suggest a manufacturing related cause.Based on the observed damage and the customer report, the probable cause of this issue is shipping/storage related.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7663821
• MDR Text Key: 113194277
• Report Number: 3006425876-2018-00417
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F17C1254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR