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

Catalog Number	982112D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2017
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 after a blood draw, the nurse went to remove the butterfly needle of a jelco® saf-t wing® blood collection and infusion set from the patient's vein and the needle separated from the plastic of the butterfly and remained in the patient's vein.The nurse then removed the needle from the patient's vein and discarded in the sharps container.No injury was reported.
Additional Manufacturer Narrative
The product, a jelco® saf-t wing® blood collection and infusion set, was not returned for inspection or evaluation.A picture of the label was provided, but the reported failure could not be confirmed by this picture.A review of the manufacturing operations, packaging operations, and quality inspection processes were reviewed and considered adequate and correct.A random sample of 32 units were taken from the packaging area while another 32 units were taken from the production floor inventory to verify for loose or detached needles.No discrepancies were found.The failure mode of the needle separating from the plastic of the butterfly could not be confirmed as the product was not returned.The root cause could not be determined as the product was not returned.

• 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: 6678485
• Report Number: 3012307300-2017-01404
• Device Sequence Number: 11255869
• Product Code: FMI
• UDI-Device Identifier: 20351688081756
• UDI-Public: 20351688081756
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 10/28/2021
• Device Catalogue Number: 982112D
• Device Lot Number: 3303230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1