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

Model Number	982106
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1900
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during blood sampling, the holder disconnected from micro-infusor leading to slight loss of blood from patient (under anticoagulant treatment).No other clinical consequence observed.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during the device history record review.

• Brand Name: JELCO BLOOD COLLECTION SAF-T WING
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13153433
• Report Number: 3012307300-2021-13500
• Device Sequence Number: 11791763
• Product Code: FMI
• UDI-Device Identifier: 20351688060508
• UDI-Public: 20351688060508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: Health Professional
• Device Model Number: 982106
• Device Catalogue Number: 982106
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown