MAUDE Adverse Event Report: ARROW INTL., INC. CVC SET: 2-LUMEN 4 FR X 8 CM; PEDIATRIC MULTI-LUMEN CATHETER PRODUCT

Catalog Number CS-15402-E

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that in the pediatric icu when transporting the 3 year old female patient from the stretcher to the bed, it was noticed that the catheter began to "exit" as a result of broken suture wings.As a result, a different access which was already in place was successfully used.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: CVC SET: 2-LUMEN 4 FR X 8 CM
• Type of Device: PEDIATRIC MULTI-LUMEN CATHETER PRODUCT
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: jody cadd, sr specialist ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3900300
• MDR Text Key: 4425262
• Report Number: 1036844-2014-00216
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2014

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 Expiration Date: 08/31/2018
• Device Catalogue Number: CS-15402-E
• Device Lot Number: 23F13G0452
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 YR