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	Needle Stick/Puncture (2462)
Date of Event	04/30/2017
Type of Reportable Event	Serious Injury
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 tubing of a jelco® saf-t wing® blood collection and infusion set pulled away from the needle, leading to a needle stick.The phlebotomist collected a venous specimen with the blood collection set from an adult patient.When the phlebotomist pulled back on the tubing to activate the safety feature, the tubing was hard to pull.The phlebotomist pulled a second time a heard the "click", which means the needle should be retracted.The tubing had pulled away from the hub of the needle.The phlebotomist picked up the butterfly and was stuck by the needle because the bevel end of the needle had not retracted.The phlebotomist disposed of the product in the sharps container.No permanent injury was reported.

• 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: 6682114
• Report Number: 3012307300-2017-01414
• Device Sequence Number: 1538615
• Product Code: FMI
• UDI-Device Identifier: 20351688081770
• UDI-Public: 20351688081770
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K895705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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: Phlebotomist
• Device Catalogue Number: 982312D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 06/30/2017
• 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