MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. HYPODERMIC NEEDLE-PRO; SYRINGE, ANTISTICK

Model Number 4429-3

Device Problem Fail-Safe Design Failure (1222)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

Two samples were returned for evaluation.Each sample was opened and insulin syringe removed.The needle shield (cap) was removed and needle cannula inspected for cleanliness and straightness.Needle cannula was then engaged within the needle-pro device per instructions for use (ifu).No issues were observed with either returned sample.Each needle cannula was observed to be straight and engaged into the needle-pro device without issue.The customer stated, "the nurse went to recap the needle and it bent back and stuck her", which suggest that attempts were made to place the needle shield (cap) back onto the syringe to cover the used needle.The ifu instructs to use the needle-pro device (not cap) following the procedure, and describes the proper method of engagement.If the cannula inadvertently became bent during use, the ifu instructs the correct procedure to follow in that event.The ifu instructs the user not to attempt to straighten the needle or to attempt to engage the needle within the needle-pro, but to discard it immediately into a sharps container.Another potential cause for a bent needle is the use of excessive force when engaging the needle within the needle-pro device.The ifu warns against using excessive engagement force.Based on the results of this investigation the complaint could not be confirmed.

Event Description

According to reporter, upon activation of the safety mechanism, the needle bent back and stuck the clinician.No adverse health outcome resulted from this event.

• Brand Name: HYPODERMIC NEEDLE-PRO
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5429562
• MDR Text Key: 37960440
• Report Number: 2183502-2016-00168
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 4429-3
• Device Catalogue Number: 4429-3
• Device Lot Number: 2888738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other