MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT:4-LUMEN 8.5FR X 30CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number DE-14854-UW

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2015

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 the catheter fixation clip which was sutured to the patient's skin did not fix the central venous catheter properly.The catheter could be moved inside the fixation clip.Due to this issue, the catheter displaced (was accidentally torn out) during repositioning of the patient.As a result a new catheter was placed.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint could not be confirmed.The customer returned a 4-lumen catheter with a clamp fastened to the body at the 10 cm mark.The clamp was removed from the body prior to decontamination.The od of the catheter body was measured and found to be within specification.The id of the clamp could not be accurately measured because it is a pliable material and it had been used.The clamp and fastener were reassembled onto the catheter body and tugged from both ends.The catheter remained secure in the clamp.It was not reported whether the clamp or the juncture hub was used as the primary suture site.A review of manufacturing records was performed based on the most recent lot shipped to the customer prior to the event.There were no relevant findings.No problem was found on the returned sample.No further action will be taken at this time.

• Brand Name: CVC KIT:4-LUMEN 8.5FR X 30CM
• 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: 5011626
• MDR Text Key: 23356825
• Report Number: 3006425876-2015-00267
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 07/29/2015

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 Catalogue Number: DE-14854-UW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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