MAUDE Adverse Event Report: COVIDIEN 1/2CC E100 SAF 29X1/2; SAFETY SYRINGE

Model Number 8881511136

Device Problems Crack (1135); Difficult to Remove (1528); Sticking (1597); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a safety syringe.The customer reports the packaging was opened and they were unable to remove the cap from the needle despite several attempts.Upon further inspection, there appeared to be a visible crack in the safety shield.The needle was not used, and the cup remained stuck on the needle.

Manufacturer Narrative

Submit date: 01/21/2014.An investigation is currently underway, upon completion the results will be forwarded.

• Brand Name: 1/2CC E100 SAF 29X1/2
• Type of Device: SAFETY SYRINGE
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer Contact: elaine bishop ; 15 hampshire st; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3663004
• MDR Text Key: 15205070
• Report Number: 1915484-2014-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014

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: Other
• Device Model Number: 8881511136
• Device Catalogue Number: 8881511136
• Device Lot Number: 331037X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 01/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1