MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., NEEDLE PRO® EDGE¿ 25G XX 5/8 WITH 3ML LL; SYRINGE, ANTISTICK

Catalog Number ED32558-CM

Device Problems Bent (1059); Fail-Safe Design Failure (1222)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

An unused, single sealed, device inside its original packaging was received for product evaluation.The reported device was not returned.Visual inspection of the returned device did not reveal any visible defects or anomalies.The needle cannula was found to be straight along the entire length and was found to be within the dimensional specification for a 25g needle.As the returned device functioned as intended, investigation could able to determine how the reported bent needle occurred.The device instruction for use instructs the user, to not attempt to engage a needle cannula within the safety sheath if the cannula is bent.No evidence was found to suggest an intrinsic product defect.

Event Description

The user facility reported that the needle bent while in patient use.When withdrawing the needle, the nurse attempted to activate the safety mechanism and a needle stick injury occurred.

• Brand Name: NEEDLE PRO® EDGE¿ 25G XX 5/8 WITH 3ML LL
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5814684
• MDR Text Key: 50172987
• Report Number: 2183502-2016-01549
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: ED32558-CM
• Device Lot Number: 2991872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other