MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVS SET: 3-LUMEN 8.5FR X 16CM; ADULT MULTI-LUMEN CATHETER PRODUCTS

Catalog Number CV-12853

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported in a resuscitation unit, the suture wings broke.The device had been stitched on the patient's skin, and the sutures remained in place.No complication, injury, no consequence or death reported.The lot number unk, there is no sample available.

Manufacturer Narrative

(b)(4).The device will not be returned.

• Brand Name: CVS SET: 3-LUMEN 8.5FR X 16CM
• Type of Device: ADULT MULTI-LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 235947; zdar nad sazavou 591 01; EZ 591 01
• Manufacturer Contact: jody cadd, sr. specialist ; 2400 bernville rd; readinag, PA 19605 ; 6103780131
• MDR Report Key: 3752989
• MDR Text Key: 16777288
• Report Number: 3006425876-2014-00027
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

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: CV-12853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: No
• 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