MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number CV-17702-E

Device Problem Partial Blockage (1065)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges the brown part of the device was found blocked during rinsing.

Manufacturer Narrative

(b)(4).Catalog# corrected to cv-17702-e.The customer returned one used two-lumen cvc for evaluation.Visual inspection was performed and no issues were identified.A lab syringe was used to pass water through both extension lines.No issues were identified.A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) that are packaged with this product cautions that to minimize the risk of damage to the extension lines from excessive pressure, each clamp must be opened prior to infusing through that lumen.The customer reported issue of the distal extension line being blocked was not confirmed during the sample investigation.Visual and functional inspections were performed and no issues were identified.As no problem was found on the returned sample no further action shall be taken at this time.

Event Description

The customer alleges the brown part of the device was found blocked during rinsing.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• 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: 7024328
• MDR Text Key: 92316414
• Report Number: 3006425876-2017-00506
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2022
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F17A0900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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