MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; NEEDLE,25GX1.5",REG,BEVEL

Catalog Number	SYR100257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Foreign Body In Patient (2687)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6)2024 while attempting to remove needle after injecting "local medication" for a "rectal exam" the needle "broke off from the hub, leaving the sharp needle itself in the tissue of the region".
Additional Manufacturer Narrative
According to the customer, on (b)(6)2024 while attempting to remove needle after injecting "local medication" for a "rectal exam" the needle "broke off from the hub, leaving the sharp needle itself in the tissue of the region".The customer reported after the incident "c-arm x rays" and a "ct scan" were performed to locate the needle.The customer reported the patient was admitted to "pacu" and had surgery on (b)(6)2024 to "remove the needle from the anterior thigh region, as noted on the ct scan".The customer reported the patient had bruising on the "right thigh and right testicle" post-operatively "as anticipated", but the bruising has since resolved.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: NEEDLE,25GX1.5",REG,BEVEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19737558
• Report Number: 1417592-2024-00738
• Device Sequence Number: 20751695
• Product Code: FMI
• UDI-Device Identifier: 40080196305576
• UDI-Public: 40080196305576
• 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): 07/14/2024

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 Catalogue Number: SYR100257
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/14/2024
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG