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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: at the time of catheterization of the artery, when the catheter is drawn, a bent guide is observed, making insertion difficult, which is why it is necessary to use another set of arterial catheterization.

Manufacturer Narrative

(b)(4).The customer returned an opened sac-00820 set containing a straight guide wire, an ldpe guard 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 ldpe guard.Visual inspection revealed the guide wire had a kink, and the ldpe guard was slightly distorted in a location that would have been consistent with the kink in the guide wire while still packaged.White stress marks were observed at the distorted location indicating the guard had previously been kinked.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 guide wire and ldpe guard to kink.Microscopic examination confirmed the kink and revealed both welds are full, intact, and spherical.The kink in the guide wire was located approximately 14.3 cm from one of the guide wire welds.The guide wire outer diameter was found to be within specification.A device history record review was performed on the kit packaging and the guide wire and no relevant issues were identified.The change history for sac-00820 was reviewed as part of the investigation.An eco was implemented in (b)(6) 2017 (after this lot was manufactured) 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.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 a kink and the protective ldpe guard was slightly distorted in a location that would have been consistent with the kink in the guide wire.In addition, the packaging contained damage as well.The damage to the packaging, the ldpe guard and the kink in the guide wire are consistent with damage caused by shipping and handling of sac-00820 sets.Since this lot was manufactured, an eco 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 pro bable cause of this issue is shipping and handling related.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: at the time of catheterization of the artery, when the catheter is drawn, a bent guide is observed, making insertion difficult, which is why it is necessary to use another set of arterial catheterization.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7549357
• MDR Text Key: 109487693
• Report Number: 3006425876-2018-00324
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/20/2022
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F17C1513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1