MAUDE Adverse Event Report: COVIDIEN 1CC SAF SYR ETB 25X 5/8; SAFETY NEEDLE/SYRINGE

Model Number 8881511235

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a safety needle/syringe combo.The customer states the nurse was done with an injection to a resident and pulled up the safety cap and placed it in her scrub coat pocket.The safety cap did not lock in place and when the nurse reached in her pocket the needle was exposed and poked her.The only way to get the safety cap to lock is to pull up and turn it.Procedure being done was a heparin shot.The shot was given and then additional care was done.The nurse closed the needle and stuck in scrub pocket.When she later reached into pocket to discard, the needle safety was not engaged and she was stuck in the finger.The nurse will go to doctor's post exposure follow-ups 6week, 3month, 6month.Whether or not the nurse was put on any medications is not given.The resident is (b)(6), employee (b)(6) at this time.

Manufacturer Narrative

Submit date: 09/28/2016.The device history record for the lot control and the shop orders indicate that product and specification requirements were met with no non-conforming product identified relating to reported condition.The manufacturing site did not receive any samples with this customer report.Without a sample, an investigation cannot be performed and the reported condition cannot be confirmed.Procedures and work instructions exist for the proper handling and verification of components and the operation of the molding, syringe assembly and packaging machine.Personnel are trained and certified in the operation of the molding, assembly and packaging equipment, product evaluation and documentation requirements.Production associates are required to visual inspect and physically test molded components to specifications as defined by the quality inspection standard.Preventive maintenance and cleaning requirements are defined for the molding machines and tools to ensure process capability is maintained.During production, the assembly and packaging equipment is checked regularly to verify the equipment is functioning properly the machine that assembles this product is equipped with vision systems that verify the presence of the lock insert and shield and a station that tests the shield function on the syringe.The machine tests every syringe and it must function within the specification limit or the machine will kick-off the syringe.During manufacturing of this product, inspectors routinely test samples for shield lock out.The results are printed out from the computer and are reviewed for each lot prior to release to verify that all testing during production was acceptable and within specification limits.The product cannot be accepted unless the acceptable quality level has been met.Per medtronic procedure, complaint trends will be evaluated during the monthly capa meeting to determine if a capa is warranted.Based on the information available and the investigation findings, a corrective and preventative action (capa) is not deemed necessary at this time.

• Brand Name: 1CC SAF SYR ETB 25X 5/8
• Type of Device: SAFETY NEEDLE/SYRINGE
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5768694
• MDR Text Key: 48727308
• Report Number: 1915484-2016-00036
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881511235
• Device Catalogue Number: 8881511235
• Device Lot Number: 524768X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other