MAUDE Adverse Event Report: AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA INC

Lot Number 34204KY

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

The customer contact reported particulate.It was reported that upon opening the package, prior to pt use, a foreign body was noted within the cannula.There were no reports of any adverse pt events or delays in critical therapies.No add'l info was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been rec'd.The list number of the device that was in use is unk.The customer contact did not provide any info about the device list number; therefore, the brand name and common device name are unk.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: UNK
• Type of Device: UNK
• Manufacturer (Section D): AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA INC; shanghai 2016 13; CH 201613
• Manufacturer (Section G): AMSINO MEDICAL CO., LTD.; shanghai 2016 13; CH 201613
• 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: 4730751
• MDR Text Key: 15915141
• Report Number: 3005515211-2015-00002
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2015

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 Lot Number: 34204KY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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