MAUDE Adverse Event Report: CAREFUSION, INC (EJ) SAFE-T PLUS BM TRAY 11G-15G; INSTRUMENT, BIOPSY

Catalog Number	BEJS4511SP
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device is not available for return.Photos were provided and a photo review is pending.The investigation is currently underway.H11: 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 prior to a bone marrow procedure, the device tray was identified damaged resulting in poor package seal integrity.It was further reported that the damaged tray was immediately removed from the case.There was no patient contact.Verbatim: rcc received a complaint via email.Email(s) attached.Received text from customer surrounding damaged case of #bejs4511.Noticed damage to trays immediately removed from case it was shipped in.Sample not available.Please see attached pictures and provide replacement 1ca asap.
Additional Manufacturer Narrative
H10: manufacturing review: a review of the device history record for part: bejs4511sp lot: 0001594063 was performed.No recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.The sterilization record for the reported product was reviewed.There were no deviations or damage reported.H10: investigation summary: the physical sample was not returned for evaluation.Three photos were provided for analysis.During the photo review process, it was found that the package was damaged, and the sterile barrier was breached.Therefore, the result of the investigation confirmed the reported damaged package - seal integrity failure.A probable root cause was unable to be determined based on the available information.H10: e4 (fda notified), g4 (date received by manufacturer), g7 type or report - follow up# 1), h2 (correction and additional information), h6 (annex g ¿ component code).H11: h3 (device eval by manufacturer), h6 (type of investigation, investigation findings, and investigation conclusions).H11: 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 prior to a bone marrow procedure, the device tray was identified damaged resulting in poor package seal integrity.It was further reported that the damaged tray was immediately removed from the case.There was no patient contact.Verbatim: rcc received a complaint via email.Received text from customer surrounding damaged case of #(b)(4).Noticed damage to trays immediately removed from case it was shipped in.Sample not available.Please see attached pictures and provide replacement 1ca asap.

• Brand Name: (EJ) SAFE-T PLUS BM TRAY 11G-15G
• Common Device Name: INSTRUMENT, BIOPSY
• 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: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 21579857
• Report Number: 1625685-2025-00023
• Device Sequence Number: 8867892
• Product Code: KNW
• UDI-Device Identifier: 10885403471568
• UDI-Public: (01)10885403471568(11)241017(17)260531(10)0001594063
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 05/31/2026
• Device Catalogue Number: BEJS4511SP
• Device Lot Number: 0001594063
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown