MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PICC KIT 4F SL PL MAX BARRIER

Catalog Number	DYNJ70141MBH
Medical Device Problem Codes	Difficult to Flush (1251); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, staff were unable to flush the picc line or obtain blood return.The facility stated that the picc line had to be removed and that a chest x-ray showed the picc line was in place.The customer reported that another company placed a picc line using their product.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, on (b)(6) 2026, staff were unable to flush the picc line or obtain blood return.The facility stated that the picc line had to be removed and that a chest x-ray showed the picc line was in place.The customer reported that another company placed a picc line using their product.

• Brand Name: MEDLINE
• Common Device Name: PICC KIT 4F SL PL MAX BARRIER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24443223
• Report Number: 3004519921-2026-00005
• Device Sequence Number: 16064406
• Product Code: LRO
• UDI-Device Identifier: 10653160362982
• UDI-Public: 10653160362982
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ70141MBH
• Device Lot Number: 2025080690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 128 KG
• Patient Race: White