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

Catalog Number DYNDSBCHLDR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/10/2022

Event Type  Injury  

Event 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.

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.

• Type of Device: 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
• MDR Text Key: 300563799
• Report Number: 1417592-2022-00179
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10193489008425
• UDI-Public: 10193489008425
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: DYNDSBCHLDR
• Device Lot Number: 211030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 75 KG