MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; WHOLE BLOOD DRAW PHLEBOTOMY

Catalog Number	DYNDB3035I
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported on (b)(6) 2026 that during a whole blood phlebotomy procedure, holes were discovered in blood collection test tubes.The defect was identified while filling the test tubes from the diversion pouch.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported on (b)(6) 2026 that during a whole blood phlebotomy procedure, holes were discovered in blood collection test tubes.The defect was identified while filling the test tubes from the diversion pouch.

• Brand Name: MEDLINE
• Common Device Name: WHOLE BLOOD DRAW PHLEBOTOMY
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center no 106; parque industrial oradel; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24840270
• Report Number: 3004122598-2026-00003
• Device Sequence Number: 5940077
• Product Code: OIB
• UDI-Device Identifier: 10195327576257
• UDI-Public: 10195327576257
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: DYNDB3035I
• Device Lot Number: 25LBE089
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/10/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown