MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 7 FR X 8" (20 CM); ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number ASK-17702-KR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

It was reported that in the operating room two hours after the procedure, the user found that the catheter that had been inserted ap proximately 15cm in depth, had migrated out of the patient's body.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint could not be confirmed through evaluation of a returned product sample.The customer provided a 2-lumen catheter with a clamp attached to the body.No defects or anomalies were observed.The outside diameter of the catheter body was within specification.The clamp id could not be accurately measured since the material is pliable and it was used.The clamp and fastener were tested by being reassembled over a pin gauge as well as back onto the catheter body and tugged from either side.The clamp remained secure.A review of manufacturing records did not yield any relevant findings.The provided instructions state that the clamp and fastener are used to secure the catheter when an additional securement site other than the catheter hub is required for stabilization.It is not known if the juncture hub was used as the primary suture site.The suture wings on the hub did not show wear from sutures or staples.Since no problem was found on the sample, the complaint could not be confirmed and no cause could be determined.No further action will be taken.

• Brand Name: CVC KIT: 2-LUMEN 7 FR X 8" (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: 5050615
• MDR Text Key: 25460423
• Report Number: 3006425876-2015-00292
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Followup
• Report Date: 08/07/2015

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: 08/31/2017
• Device Catalogue Number: ASK-17702-KR
• Device Lot Number: 71F15B1076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• 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