MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 4-LUMEN 8.5 FR X 8"; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number ASK-15854-KR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint could not be confirmed.The customer returned one 4-lumen catheter with a catheter clamp and fastener attached at the distal tip.The catheter and clamp appeared typical and met specification.The clamp is made from a pliable material and was used so the internal diameter could not be measured.The clamp and fastener were reassembled and performed as intended and would secure the catheter.A review of manufacturing records did not yield any relevant findings.The instructions for use state that the juncture hub should be used as the primary suture site.It was not reported which sites were used to suture the catheter.Since no problem was found on the returned sample, not cause could be determined.No further action will be taken.

Event Description

It was reported that in the icu, one or two days after the catheter was inserted into the patient's internal jugular vein, the user found that the catheter had "fallen out" from the patient's body despite having been secured with sutures.As a result, it was replaced with a new one without issue or injury to the patient.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(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.

• Brand Name: CVC KIT: 4-LUMEN 8.5 FR X 8"
• 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 01; EZ 591 01
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4810694
• MDR Text Key: 13306623
• Report Number: 3006425876-2015-00181
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2015

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: 05/31/2017
• Device Catalogue Number: ASK-15854-KR
• Device Lot Number: 71F14L0514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 06/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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