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 08/20/2015

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 during use, the catheter clamp and the blue clamp were slightly detached from the catheter.As a result, the catheter was slightly pulled out of the patient.The md saw the patient touching it over the dressing, however, did not suspect it was the cause of the complaint.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

(b)(4).Device evaluation: the reported complaint could not be confirmed.The customer returned one catheter along with a box clamp and fastener.The sample showed signs of use and the distal tip of the catheter was cut off and not returned.Further examination revealed that the box clamp and fastener were present on the catheter body, but no sutures were present on the juncture hub or clamp upon return.The od of the catheter met specification.The id of the clamp could not be measured since the material is pliable and it had been used.However, the clamp and fastener were reassembled on the catheter body and were found to be secure.A review of manufacturing records did not yield any relevant findings.The provided instructions state that the juncture hub is the primary suture site and the clamp is the secondary.It was not reported if the hub was sutured and no evidence of use was found on the suture wings.No problem was found with the returned sample.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: 5050716
• MDR Text Key: 24895640
• Report Number: 3006425876-2015-00294
• 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: 08/20/2015

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: 11/30/2017
• Device Catalogue Number: ASK-17702-KR
• Device Lot Number: 71F15D0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• 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: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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