MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 8 FR X 16 CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CS-12802

Device Problem Detachment Of Device Component (1104)

Patient Problem Injury (2348)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that during the insertion of the cvc by the anesthetist, the puncture needle separated from its holder.The needle had to be removed with an immediate surgery intervention.There were no clinical consequences for the patient as a result of the incident and the patient is fine.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint was confirmed through evaluation of a returned product sample.The customer provided an 18 ga.Introducer needle which was separated from its hub.Microscopic examination revealed no evidence of adhesive material in the hub and a small area of adhesive on the cannula.A review of manufacturing records did not yield any relevant findings.However, the probable cause is manufacturing related.Further investigation has been initiated at the manufacturing site.

• Brand Name: CVC SET: 2-LUMEN 8 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 01; EZ 591 01
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4860007
• MDR Text Key: 5848070
• Report Number: 3006425876-2015-00207
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: CS-12802
• Device Lot Number: 71F15B1477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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
• Patient Outcome(s): Required Intervention