MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	982312D
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the nurse was unable to retract the needle of a jelco® saf-t wing® blood collection and infusion set into the housing.The needle would only retract half way.Needle was disposed of in sharps container.No injury to patient or clinician was reported.
Additional Manufacturer Narrative
Eight devices were returned for evaluation in new condition.Visual inspection of the devices found no discrepancies.Simulated use testing was performed and found no discrepancies; the safety mechanism activated without issue.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed and found no discrepancies.A sample of 5 devices was taken from production and functionally tested via simulated use testing and found that there were no difficulties activating the safety mechanism.Based on the evidence, a root cause was unable to be confirmed.No fault was found with the devices.

• Brand Name: JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6694491
• Report Number: 3012307300-2017-01432
• Device Sequence Number: 11205607
• Product Code: FMI
• UDI-Device Identifier: 20351688081770
• UDI-Public: 20351688081770
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K895705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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
• Operator of Device: Nurse
• Device Expiration Date: 04/04/2022
• Device Catalogue Number: 982312D
• Device Lot Number: 3401837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1