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)
Date of Event	06/19/2017
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 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
The product, a jelco® saf-t wing® blood collection and infusion set, was not returned for inspection or evaluation.Two photos were instead returned.From the first photograph, it can be seen that the needle is outside the safety device.However, in the second photograph, it is observed that the needle is retracted inside the safety device.A review of the assembly and packaging operations were reviewed and considered adequate and correct.A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct.A sample of 5 units were taken from production in order to activate the safety mechanism.No discrepancies were found in the samples.No root cause has been determined as the complaint was not confirmed due to no sample returned for evaluation.

• 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: 6694487
• Report Number: 3012307300-2017-01431
• Device Sequence Number: 531493
• 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): 05/07/2018

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: 07/10/2017
• 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: 04/10/2018
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1