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

Catalog Number	DYNDSBCHLDR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022 'the butterfly needle was removed from the patients arm and pulled up to put the safety lock on the needle, and once they pulled up the line detached from the hub splashing blood everywhere'.Per the facility the employee was put on a 5 day medication called prep and was required to have blood work done, with additional blood work required in 6 months.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 'the butterfly needle was removed from the patients arm and pulled up to put the safety lock on the needle, and once they pulled up the line detached from the hub splashing blood everywhere'.Per the facility the employee was put on a '5 day medication called prep and was required to have blood work done, with additional blood work required in 6 months'.Per the facility the sample is not available to be returned for evaluation.No additional information is available at this time.Due to the reported incident and 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: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15477108
• Report Number: 1417592-2022-00179
• Device Sequence Number: 20232677
• Product Code: FPA
• UDI-Device Identifier: 10193489008425
• UDI-Public: 10193489008425
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/23/2022

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
• Device Lot Number: 211030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/24/2022
• 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: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 75 KG