MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BONE MARROW BIOPSY NEEDLE 11GA X 4IN

Model Number	DBMNJ1104
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
P23-151 nursing assistant who, while assisting the institution's hematologist to perform a bone marrow biopsy on a patient, when he was preparing to discard the medical device, when encapsulating the needle in the "safety shoes", it did not fit, so the assistant removed the needle again and tried again, but the ¿safety shoe¿ opened, causing the nurse to puncture herself, creating a puncture wound with the biopsy needle.
Additional Manufacturer Narrative
Sample is not available for return.Argon is investigating this reported event and submit a follow-up report upon investigation completion.
Event or Problem Description
P23-151 nursing assistant who, while assisting the institution's hematologist to perform a bone marrow biopsy on a patient, when he was preparing to discard the medical device, when encapsulating the needle in the "safety shoes", it did not fit, so the assistant removed the needle again and tried again, but the ¿safety shoe¿ opened, causing the nurse to puncture herself, creating a puncture wound with the biopsy needle.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot number was conducted.There were no deviations or nonconformances noted.The customer has stated that no sample is available to return for evaluation.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for determination of cause for failure and necessary corrective action.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: BONE MARROW BIOPSY NEEDLE 11GA X 4IN
• Common Device Name: BONE MARROW BIOPSY NEEDLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18193658
• Report Number: 0001417485-2023-00009
• Device Sequence Number: 18071263
• Product Code: KNW
• UDI-Device Identifier: 00886333001484
• UDI-Public: (01)00886333001484(17)280519(10)11477092
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DBMNJ1104
• Device Lot Number: 11477092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 09/01/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 11/29/2023; 09/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown