MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP

Catalog Number AK-45703-BCDC

Device Problems Product Quality Problem (1506); Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2017

Event Type  malfunction  

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.

Event Description

The customer alleges the introducer needle was jagged with a sharp edge that caught the wire causing it to get stuck and unravel. There was no patient injury or consequence. The patient is reported as "fine". It is unknown if therapy was interrupted/delayed.

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges the introducer needle was jagged with a sharp edge that caught the wire causing it to get stuck and unravel. There was no patient injury or consequence. The patient is reported as "fine". It is unknown if therapy was interrupted/delayed.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7074503
• MDR Text Key: 189051131
• Report Number: 3003737899-2017-00125
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2018
• Device Catalogue Number: AK-45703-BCDC
• Device Lot Number: 13F17D0306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial