MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PICC LINE INSERTION PACK

Catalog Number	DYNJ38868N
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the 1% lidocaine vial supplied in the picc pack was cracked and leaking fluid in the foam wrapper it comes in.Appeared to have a hairline crack in the bottom of the vial.".
Additional Manufacturer Narrative
The account reported finding cracked vial; the 1% lidocaine vial supplied in the picc pack was cracked and leaking fluid in the foam wrapper and appeared to have a hairline crack in the bottom of the vial.No sample or photo was received for the investigation; finished good production records, the finished good pack build/bom, and component trending were reviewed, and the manufacturer did not find any discrepancies within their records or retained samples that could have contributed to the reported issue.Based on the complaint details and the investigation, the complaint is not confirmed, and the investigation was limited without a photo or sample provided by the customer for evaluation.A root cause was not identified; the recorded cause was "sample required to determine cause," and the division will 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: PICC LINE INSERTION PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867696
• Report Number: 1417592-2026-48610
• Device Sequence Number: 9379689
• Product Code: LRO
• UDI-Device Identifier: 10198459036835
• UDI-Public: 10198459036835
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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): 09/22/2026

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: DYNJ38868N
• Device Lot Number: 25DBH378
• 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: 07/11/2025
• Initial Report FDA Received Date: 09/23/2026
• 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