MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO IV CATHETER

Model Number CI+2050-2C

Device Problem Break (1069)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturer investigation report attached on retained samples.Device not returned.To manufacturer.

Event Description

Medwatch report # mw5062232 received by mail 6/15/2016: iv inr and ac placed on (b)(6) 2016, working fine.Last "normal" use of iv was at 1811(6:11p.M.), flushed and hung iv antibiotic, site was noted to be working fine.Next use was at 2011 (8:11p.M.), went to "flush" iv site, noted iv leaking all over.Untaped iv and noted pink hub, unable to see white catheter tip - noted to be "gone".Not on tape, not visible to the naked eye.Unable to be palpated to touch.Diagnosis or reason for use of iv: pneumonia.

• Brand Name: NIPRO IV CATHETER
• Type of Device: IV CATHETER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, niida-aza; ohdate-shi, akita; 018-5 794; JA 018-5794
• Manufacturer (Section G): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, niida-aza; ohdate-shi, akita; 018-5 794; JA 018-5794
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 5746346
• MDR Text Key: 48093851
• Report Number: 9610987-2016-00005
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K960051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/23/2016

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: 07/31/2020
• Device Model Number: CI+2050-2C
• Device Lot Number: 15H25B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2016
• Distributor Facility Aware Date: 06/15/2016
• Device Age: 9 MO
• Date Report to Manufacturer: 06/23/2016
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization