MAUDE Adverse Event Report: ICU MEDICAL/HOSPIRA DOUBLE CONNECTOR 12009

Model Number 12009

Device Problems Particulates (1451); Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 01/18/2016

Event Type  malfunction  

Event Description

Female-female luer adapters, mfg by icu medical and sold by hospira have translucent particles in the packaging and on the sterile devices.These appear to be plastic bits left over from the mfg process.These bits of plastic are concerning as they could result in embolism or other foreign body events.This is the 2nd lot with which this has occurred.Hospira was notified, but no one from hospira has contacted us for more info and to request that we send the product for eval.Icu medical, inc.Double connector 12009 lot 57-719-sl.

• Brand Name: DOUBLE CONNECTOR 12009
• Type of Device: DOUBLE CONNECTOR 12009
• Manufacturer (Section D): ICU MEDICAL/HOSPIRA; san clemente CA 92673
• MDR Report Key: 5396793
• MDR Text Key: 37088714
• Report Number: MW5059725
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2016

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: 09/30/2020
• Device Model Number: 12009
• Device Lot Number: 57-719-SL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1