MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4; BIOPSY NEEDLE

Model Number	TJC4011
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It does not have a sanitary registration number on the packaging according to the provisions of cofepris high directives, since it is a measure to avoid the entry of counterfeit, altered and/or adulterated supplies.Email translation: a few days ago, 2 pieces of hamshidi needle (or hamshidi type) were detected in the warehouse that do not have a sanitary registration number on the packaging.In accordance with the provisions of the high sanitary directive of cofepris, ensuring that medicines and other health supplies have a sanitary registration, alpha numerical key or any other authorization or notification is one of the measures to prevent the entry of falsified, altered and / or adulterated supplies into the supply chain, so i ask you to carefully review this issue with the suppliers of these supplies (oc 1847 and 1853).Note: i requested to quarantine the supplies until this situation is clarified.
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a2101 patient problem code: (b)(6).
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, it was observed that the artwork for the revision provided in the sample photo matches the artwork of that revision on file; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001406493 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacture narration.
Event or Problem Description
It does not have a sanitary registration number on the packaging according to the provisions of cofepris high directives, since it is a measure to avoid the entry of counterfeit, altered and/or adulterated supplies.Email translation: a few days ago, 2 pieces of hamshidi needle (or hamshidi type) were detected in the warehouse that do not have a sanitary registration number on the packaging.In accordance with the provisions of the high sanitary directive of cofepris, ensuring that medicines and other health supplies have a sanitary registration, alpha numerical key or any other authorization or notification is one of the measures to prevent the entry of falsified, altered and / or adulterated supplies into the supply chain, so i ask you to carefully review this issue with the suppliers of these supplies (oc 1847 and 1853).Note: i requested to quarantine the supplies until this situation is clarified.

• Brand Name: JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 15528389
• Report Number: 1625685-2022-00090
• Device Sequence Number: 6079410
• Product Code: FCG
• UDI-Device Identifier: 10885403044052
• UDI-Public: (01)10885403044052
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K913306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: TJC4011
• Device Catalogue Number: TJC4011
• Device Lot Number: 0001406493
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown