MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SPINE PACK 24932-SW-LF

Catalog Number	DYNJ64882D
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2024 when the needle was recapped it "poked through the cap" and when the needle was being "unscrewed" the scrub tech was "poked".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 when the needle was recapped it "poked through the cap" and when the needle was being "unscrewed" the scrub tech was "poked".The customer reported the incident occurred after the needle was used on a patient and the patient was "hep c positive".The customer reported they "assume follow up care will be necessary" but, the scrub tech "is fine".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: SPINE PACK 24932-SW-LF
• 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: 18975701
• Report Number: 1423395-2024-00369
• Device Sequence Number: 6299334
• Product Code: OJH
• UDI-Device Identifier: 40195327551569
• UDI-Public: 40195327551569
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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: DYNJ64882D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• 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 Sex: Unknown