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 needle of a jelco® saf-t wing® blood collection and infusion set was difficult to retract into the "housing".No injury was reported.
Additional Manufacturer Narrative
Six used and two unused jelco saf-t wing blood collection and infusion sets were returned for investigation.The device history records for the devices were reviewed and no relevant findings were detected.The returned samples were visually inspected and no discrepancies were found.Functional testing was performed and there were difficulties to activate the safety mechanism in two of the samples; the tube showed resistance when pulling it to activate the safety mechanism.The other six samples did not present difficulties when activating the safety mechanism.A manufacturing review for a similar device was performed and there were no difficulties when activating the safety mechanism of the five manufactured units.The complaint was confirmed.The most probably root cause was determined to be: defective part (safety mechanism) was received from the supplier.Defective safety mechanism was not detected on receiving inspection due to the fact that no inspection and testing was performed since the component is on "certified status".The defective safety mechanism was not detected through the manufacturing process inspection due to there not being testing on the safety mechanism in place in the manufacturing process.

• 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: 6619527
• Report Number: 3012307300-2017-01206
• Device Sequence Number: 14586
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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: No Information
• Device Expiration Date: 03/27/2022
• Device Catalogue Number: 982312D
• Device Lot Number: 3397154
• 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: 05/23/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1