MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 16 CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CV-12703

Device Problems Migration or Expulsion of Device (1395); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that in the medical resuscitation unit, when the nurse moved the patient she heard a noise and then noticed that the catheter had been expelled.After analyzing the device, it was noticed that the fixation wing was split.There were no clinical consequences for the patient as a result of the incident.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint was confirmed through examination of a returned product sample.The customer provided a 3- lumen catheter with a suture wing that was split.The observed damage is consistent with what occurs when excess force is applied to a catheter that is sutured in place.A review of manufacturing records did not yield any relevant findings.The provided instructions direct the user to use the triangular juncture hub as the primary suture site and the catheter clamp as a secondary suture site as necessary.It was not reported if the catheter clamp was used as a suture site.Since it appears that the suture wing damage occurred during movement of the patient, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: CVC SET: 3-LUMEN 7 FR X 16 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: 5240477
• MDR Text Key: 31764264
• Report Number: 3006425876-2015-00353
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Initial,Followup
• Report Date: 11/12/2015

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: 02/29/2020
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F15F0636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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