MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER, PERCUTANEOUS

Catalog Number ES-04301

Device Problems Device Damaged Prior to Use (2284); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the guide is shown folded in the distal part.The issue was detected prior to use.The procedure is performed with the device and without complications.

Event Description

The customer reports the guide is shown folded in the distal part.The issue was detected prior to use.The procedure is performed with the device and without complications.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7421470
• MDR Text Key: 105423279
• Report Number: 9680794-2018-00072
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 03/27/2018

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: No Information
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: ES-04301
• Device Lot Number: 14F17J0117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 63