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

Model Number	982312D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon retracting the needle from the patient's arm the tubing broke and blood spattered on the medics arms and upper torso.No adverse patient or clinical effects were reported by the customer.
Additional Manufacturer Narrative
Date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No device was returned for investigation, no root cause determined.Device history review of the reported lot number showed no non-conformities during the manufacturing process.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16873556
• Report Number: 3012307300-2023-05112
• Device Sequence Number: 20648475
• Product Code: FMI
• UDI-Device Identifier: 20351688081770
• UDI-Public: 20351688081770
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 982312D
• Device Catalogue Number: 982312D
• Device Lot Number: 4315713
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown