MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SYR W/NDLE,HYPODERM,TB,27GX 1/2", 1M

Catalog Number	SYR101272
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "subcutaneous injection was being administered with the tuberculin syringe and during administration the entire hub shot off from the syringe lost half of solution.Re-assessed by using 2 other syringes.Same result.".
Additional Manufacturer Narrative
The customer states they used only 3 of the syringes out of the entire case and 2 of them fell apart, states the needle is unstable, and reported that during administration the entire hub shot off from the syringe lost half of solution.Medline received 1cs, syr101272 standard hypodermic syringe with needle in new condition, randomly selected 50 samples to perform a visual inspection and functional testing by inserting each syringe into a training pad, and tested for leakage after fluids were drawn from a training vial and then flushed.The complaint was not confirmed: the visual inspection revealed no manufacturing or any other defects, there were no indications of any of the needles detaching from their hub, all needles and syringes remained attached at all times, and no leakage was seen from the needle, hub, or plunger/barrel.The cause was documented as unconfirmed defect / not confirmed with received sample, the samples worked as intended, and there were no reports of patient injury or indications of nonconforming product based on the investigation details.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-SYR W/NDLE,HYPODERM,TB,27GX 1/2", 1M
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803257
• Report Number: 1417592-2026-43446
• Device Sequence Number: 18777641
• Product Code: FMF
• UDI-Device Identifier: 40080196448815
• UDI-Public: 40080196448815
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Device Catalogue Number: SYR101272
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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