MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP; BONE MARROW COLLECTION/TRANSFUSION KIT

Catalog Number	BAK4511
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.The device has not been returned.The investigation is currently underway.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that a jamshidi bone marrow tray contained a hair inside one of the sterile bone marrow biopsy kits.No injuries or adverse events occurred.Only one kit was affected, and no sample is available for return as the practitioner discarded the kit and opened a new one before taking a photo.
Event or Problem Description
It was reported that a jamshidi bone marrow tray contained a hair inside one of the sterile bone marrow biopsy kits.No injuries or adverse events occurred.Only one kit was affected, and no sample is available for return as the practitioner discarded the kit and opened a new one before taking a photo.
Additional Manufacturer Narrative
H11: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001610926 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.Awareness training was conducted with the finished goods packaging team in response to this incident.G4: pma/510(k): k171531; k813338.G3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h6: annex g (component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
• Common Device Name: BONE MARROW COLLECTION/TRANSFUSION KIT
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 23247885
• Report Number: 1423507-2025-00095
• Device Sequence Number: 10313612
• Product Code: LWE
• UDI-Device Identifier: 10885403057236
• UDI-Public: (01)10885403057236(17)260831(10)0001610926
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: 08/31/2026
• Device Catalogue Number: BAK4511
• Device Lot Number: 0001610926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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