MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5"

Catalog Number	SYRSI101292Z
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Other
Event or Problem Description
It was reported that "can¿t fill them up with anything without the needle retracting and being un-usable" and "we can¿t use without needle getting exposed/retracted.".
Additional Manufacturer Narrative
The customer reported that they ¿can¿t fill them up with anything without the needle retracting and being un-usable¿ and ¿can¿t use without needle getting exposed/retracted.¿ medline received 2 boxes of syringes in new condition, randomly selected 30 samples, performed visual inspection, removed the caps, filled each sample with water up to 50 units and then up to 100 units, slowly pulled out the plungers to the desired amount, and removed the fluids without any issue.The complaint was not confirmed; visual inspection found no manufacturing or any other defect preventing the samples to work properly, no issues were experienced with the safety feature being engaged during this process or the needle becoming exposed, and the safety shield only activated when excessive force was used.The documented cause was ¿not confirmed with received sample,¿ and based on the review of the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications.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: DBQ-SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804770
• Report Number: 1417592-2026-43754
• Device Sequence Number: 18367810
• Product Code: FMF
• UDI-Device Identifier: 20888277657295
• UDI-Public: 20888277657295
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K231907
• 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): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: SYRSI101292Z
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2023
• 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: 02/17/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown