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

Catalog Number SAC-00820

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

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Prior to insertion of the arterial line, the guide showed a folded catheter guide.The issue was detected prior to patient use.

Event Description

Prior to insertion of the arterial line, the guide showed a folded catheter guide.The issue was detected prior to patient use.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened sac set with a straight guide wire and a single-lumen arterial catheter for analysis.Visual analysis revealed that the guide wire contained one distinct kink.The outside packaging of the sac was also noted to have multiple folds and creases in it.Microscopic examination revealed both welds were intact and confirmed the kink.The damage observed is consistent with defects related to shipping and handling of sac sets.No other defects or anomalies were observed.The kink in the guide wire measured 195mm from the proximal tip.The guide wire length measured 350mm , which is within the specification limits of 345mm-355mm per the guide wire product drawing.The guide wire outer diameter measured 0.516mm, which is within the specification limits of 0.508mm-0.533mm per the guide wire product drawing.A manual tug test confirmed the distal and proximal welds were attached.A device history record review was completed with no relevant findings.The lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.And engineering change order was implemented in april 2017 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 one distinct kink and a couple minor bends.The words "do not bend" are clearly visible on the front of the lidstock, which is intended to heighten customer awareness and mitigate the risk of kinking the components during storage and shipping of this product.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer description and the sample received, storage and shipping caused or contributed to this event.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: 9666026
• MDR Text Key: 180321173
• Report Number: 3006425876-2020-00112
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F19G2986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1