MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS (TJ) NEEDLE ASPIRATION 18GA- TIN3018; BONE MARROW COLLECTION/TRANSFUSION KIT

Model Number	TIN3018
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Due to stock inspection we¿ve identified 2 x 18g jamshidi bone marrow biopsy needle (lot 0001395413) with needle protector to become detached within the packaging, which let needle of the device to puncture the packaging compromising the sterile barrier.I will be rejecting all our stock of (b)(4) x (lot 0001395413 & 0001390010) and sending back to you as it could result in potential injury for our workers or customers.Needle sticking through pack.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one photo was provided to our quality team for investigation.Through visual inspection it was observed that the detached needle protector next to the needle in the pouch therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 0001395413, 0001390010 were 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.A corrective action project was opened to further investigate and address this issue.This capa addresses package damaged from disconnected needle protectors, loose needle protectors, and bent needles.The updates will reduce the potential for needles being loose from protectors.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 manufacturer here.
Event or Problem Description
Due to stock inspection we¿ve identified 2 x 18g jamshidi bone marrow biopsy needle (lot 0001395413) with needle protector to become detached within the packaging, which let needle of the device to puncture the packaging compromising the sterile barrier.I will be rejecting all our stock of 321 x (lot 0001395413 & 0001390010) and sending back to you as it could result in potential injury for our workers or customers.Needle sticking through pack.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 18GA- TIN3018
• Common Device Name: BONE MARROW COLLECTION/TRANSFUSION KIT
• 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: 13770193
• Report Number: 1625685-2022-00038
• Device Sequence Number: 12020176
• Product Code: LWE
• UDI-Device Identifier: 10885403043819
• UDI-Public: (01)10885403043819
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/15/2022

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: 11/30/2025
• Device Model Number: TIN3018
• Device Catalogue Number: TIN3018
• Device Lot Number: 0001395413
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/15/2022
• 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