MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SCISSORS,OR,SHARP/BLUNT,5.5",STERILE

Catalog Number	DYND04000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Injection Site Reaction (4562)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i was using a pair and had a sliver of metal puncture my finger just before attempting to access a picc" and "this is the same lot of scissors that have been hit or miss during use.".
Additional Manufacturer Narrative
The account reported finding loose metal sliver on scissors, and the user claims they punctured their finger but there is no further information on the extent of the injury or whether medical treatment required.No sample or photo received for our investigation; finished good production records reviewed found no run without approvals, deviations or non-conformance reports that might have had an impact on this issue, and finished good pack build reviewed found no issues with the build that likely contributed to the reported issue.Per the complaint details, we were unable to confirm the reported issue due to no sample or photo being received, and with the information provided we are not able to confirm at what point the damage occurred or what may have caused it.This complaint has been provided to the vendor for further evaluation, and the supplier quality team will also monitor this issue for trending purposes.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: SCISSORS,OR,SHARP/BLUNT,5.5",STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945611
• Report Number: 1417592-2026-54109
• Device Sequence Number: 9534237
• Product Code: HRR
• UDI-Device Identifier: 40080196824220
• UDI-Public: 40080196824220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/29/2026

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: DYND04000
• Device Lot Number: 23BBQ676
• Was Device Available for Evaluation?: No
• 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: 07/12/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (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