MAUDE Adverse Event Report: ICU MEDICAL, INC. ARTERIAL BLOOD GAS KIT PRO-VENT; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4698PE
Medical Device Problem Codes	Particulates (1451); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pro-vent plus syringe black marker traces were noticed on the syringe, especially around the plunger.The affected syringe was immediately withdrawn.The incident was noticed before use on patient, during the preparation in the treatment room.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
D9: date returned to mfg.: 7/14/2025.D3 - mfg establishment name, h3 and h6.Codes: updated.Device evaluation: received for investigation one unused package of the suspected product.Review of the provided sample showed black markings on the syringe barrel and along the finger flange, thus complaint confirmation.The syringe barrel is a supplied component and sent with graduation markings pre-printed.Icu medical manufacturing does not impact print quality on supplied barrels.During the manufacturing process testing of the heparin and silicone weights are required.The test samples are to be accounted for and not packaged into finished goods.It's possible that one of the test samples was inadvertently packaged into a finished good.As a precaution, a quality alert has been submitted to the manufacturing floor.No further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions taken accordingly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue has no history of associated risk.

• Brand Name: ARTERIAL BLOOD GAS KIT PRO-VENT
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): ICU MEDICAL, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22286898
• Report Number: 3012307300-2025-07282
• Device Sequence Number: 8819909
• Product Code: JKA
• UDI-Device Identifier: 20351688039115
• UDI-Public: (01)20351688039115(17)261016(10)4434667
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: 4698PE
• Device Lot Number: 4434667
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown