MAUDE Adverse Event Report: HOSPIRA LTD. NDEHP MICR YTYPE CLV; 80FPK

Catalog Number 20655

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

The customer contact reported a separation.It was reported that the customer "tested" the tubing set by applying minimal tension between the leg of the y-connector and tubing.At that time, the tubing separated from the leg of the y-connector.There was no reported adverse effect or delay of therapy to any patient.No medical interventions were required.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: NDEHP MICR YTYPE CLV
• Type of Device: 80FPK
• Manufacturer (Section D): HOSPIRA LTD.; carretera sanchez, km 18 1/2; parque industrial; haina, san cristobal ; DR
• Manufacturer (Section G): HOSPIRA LTD.; carretera sanchez, km 18 1/2; parque industrial; haina, san cristobal ; DR
• Manufacturer Contact: juergen schmider, md, vp. ; 275 n. field dr.; bldg. no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4620455
• MDR Text Key: 5764881
• Report Number: 9613251-2015-00028
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20655
• Device Lot Number: 352174W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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