MAUDE Adverse Event Report: ST PAUL LEVEL 1 TRAUMA FAST FLOW DISPOSABLES; DEVICE, WARMING. BLOOD AND PLASMA

Model Number	DI-100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported of a device malfunction (water leak).Lot unknown.Discovered upon opening.No injury.
Additional Manufacturer Narrative
Device manufacturing date and d4: device expiration date could not be determined device serial number/lot number is unknown.Event problem and evaluation codes: updated no lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found no damages nor other workmanship defects were detected.Functional testing found a leak is observed at the drip chamber.The root cause of the reported issue was found to be a lack of a robust and repeatable adhesive dispensing method, since currently the adhesive application relies on the operators ability to achieve the desired 1/8? dipping depth.Updated manufacturing process by adding an automated solvent dispenser instead of the manual process to improve consistency for meeting the process requirements.This issue is being monitored via an internal cat.If the occurrence of this issue increases significantly, additional corrective actions will be taken.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1 TRAUMA FAST FLOW DISPOSABLES
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16725375
• Report Number: 3012307300-2023-04020
• Device Sequence Number: 7989469
• Product Code: KZL
• UDI-Device Identifier: 20695085410017
• UDI-Public: 20695085410017
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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 Model Number: DI-100
• Device Catalogue Number: DI-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown