MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SAFETY TUBE HOLDER, BLOOD COLLECTION

Catalog Number	DYNDSBCHLDR
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2022 'while the nurse tried to put the safety cap on, it broke off the top of the luer, and blood sprayed all over the nurse's face and in her left eye'.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2022 'while the nurse tried to put the safety cap on, it broke off the top of the luer, and blood sprayed all over the nurse's face and in her left eye'.The customer reported the nurse washed her eye out and went to occupational health but, required no further treatment.The customer reported no serious injury occurred related to this event.Sample is not available for return.No additional information is available at this time.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.

• Common Device Name: SAFETY TUBE HOLDER, BLOOD COLLECTION
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16195364
• Report Number: 1417592-2023-00024
• Device Sequence Number: 12210968
• Product Code: FMI
• UDI-Device Identifier: 10193489008425
• UDI-Public: 10193489008425
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

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 Catalogue Number: DYNDSBCHLDR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown