MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	402558
Medical Device Problem Codes	Bent (1059); Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number: the lot was reported as "289001", which is not considered a valid lot number.Potential lot number: 3289001.Potential expiration date: 09/23/2021.Potential device manufacturer's date: 10/11/2016.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a jelco® hypodermic needle-pro® edge¿ safety device was activated during use and upon activation, the needle bent out of the safety device and the clinician experienced a needlestick.It was noted that the clinician activated the device away from themselves on a hard surface.The clinician was tested, evaluated, and counseled related to the incident.No permanent injury was reported.See mfr: 3012307300-2017-00509 and 3012307300-2017-00575.
Additional Manufacturer Narrative
Two used 25g x 5/8" jelco® hypodermic needle-pro® edge¿ safety devices were returned for investigation.The samples were received inside a plastic container without their original packaging.Visual inspection revealed that the needle cannula of one of the returned samples was bent upwards (not straight) and was not fully engaged within the needle-pro® edge device.Visual inspection of the second sample found that the needle cannula was broken near the hub; a stub of the needle cannula remained intact.The broken portion of the needle cannula was also returned and was examined and it was observed that the tip of the needle cannula was bent.Both returned samples were then inspected microscopically and no mold defects or processing issues were observed.An attempt to recreate the observed needle cannula bend was conducted on unused samples of the product that were stored in the warehouse.All samples were found to successfully engage into the safety device even when the samples were held at an angle and/or were engaged on a non-firm surface while using excessive force.Additionally, a review of the reported event found that the customer was able to successfully administer the medication prior to attempting to engage the needle which indicated that the samples were not bent prior to use.Investigation was unable to definitively determine a root cause for the bent and broken needle cannulas; however, no evidence was found to suggest a manufacturing defect.

• Brand Name: JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6350178
• Report Number: 3012307300-2017-00510
• Device Sequence Number: 13686202
• Product Code: FMI
• UDI-Device Identifier: 30351688066552
• UDI-Public: 30351688066552
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K071785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 402558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other