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

Catalog Number CV-17702

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2015

Event Type  malfunction  

Event Description

It was reported the catheter was being used in a female patient's subclavian and she was receiving vancomycine.The clinician reported there was a problem with the suture and the catheter migrated out of the insertion site.As a result, a new catheter was placed.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed because no sample was returned for analysis.A review of manufacturing records did not yield any relevant findings.The probable cause could not be determined based upon the information provided and without a sample.No further action will be taken.

• Brand Name: CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: ADULT MULTI LUMEN CATHETER PRODUCTS
• 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: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4894296
• MDR Text Key: 6019893
• Report Number: 3006425876-2015-00226
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2015

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: CV-17702
• Device Lot Number: 71F15C1426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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