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

Catalog Number 0020003050

Device Problem Crack (1135)

Patient Problem Laceration(s) (1946)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that a vial broke while the lab technician tried to open it and caused an injury.

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)
• Type of Device: 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
• MDR Text Key: 334847609
• Report Number: 1217183-2024-00001
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 08426950447627
• UDI-Public: 08426950447627
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0020003050
• Device Lot Number: N0431117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1