MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL RECOMBIPLASTIN 2G (20 ML); PROTHROMBIN TIME TEST

Catalog Number	0020003050
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vial broke while the lab technician tried to open it and caused an injury.
Additional Manufacturer Narrative
A complaint was submitted on hemosil recombiplastin 2g, pn 00020003050, lot n0431117, indicating that a vial broke while the lab technician tried to open it and caused an injury.The customer indicated the vial appeared to explode.There was no known adverse effect from the injury.First aid treatment was administered.A photo was provided of the broken bottom of the recombiplastin 2g vial; the lot information was not visible.The vial stopper and white screw cap were still in place.Review of the device history records and visual inspection of recombiplastin 2g lot n0431117 was performed, no abnormalities or issues were identified.Vials are stoppered under vacuum and not pressurized in a way that could lead to an 'explosion'.Unable to determine root cause of the broken vial.

• Brand Name: HEMOSIL RECOMBIPLASTIN 2G (20 ML)
• Common Device Name: PROTHROMBIN TIME TEST
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01821
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730 ; 7818614451
• MDR Report Key: 18629808
• Report Number: 1217183-2024-00001
• Device Sequence Number: 7834924
• Product Code: GJS
• UDI-Device Identifier: 08426950447627
• UDI-Public: 08426950447627
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070005
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 0020003050
• Device Lot Number: N0431117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (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