MAUDE Adverse Event Report: COVIDIEN MONOJECT HEPARIN LOCK; 100 UNITS / ML

Lot Number 13C0674N

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

Received a package of heparin lock syringes.One of the syringes received in the box has no markings, lot number, or labeling of any kind.It also looks different in color than the other injections of the same box.

• Brand Name: MONOJECT HEPARIN LOCK
• Type of Device: 100 UNITS / ML
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 3634092
• MDR Text Key: 15821040
• Report Number: MW5034525
• Device Sequence Number: 1
• Product Code: NZW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 13C0674N
• Other Device ID Number: 8881590125
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1