MAUDE Adverse Event Report: CAREFUSION, INC SAFETY SOFT TISSUE BIOPSY TRAY; TRAY, SURGICAL, NEEDLE

Catalog Number	4382SP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that some foreign material was found in the sterile safety soft tissue biopsy tray.It was further reported that on assessment afterward nursing manager palpated debris and described it as " hard, like cardboard".
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records has not been performed.The device is pending return.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 some foreign material was found in the sterile safety soft tissue biopsy tray.It was further reported that on assessment afterward nursing manager palpated debris and described it as " hard, like cardboard".
Additional Manufacturer Narrative
H11: g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h3 (device eval by manufacturer) a device was not returned for evaluation.Upon completion of the investigation, another supplemental report will be filed.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.
Additional Manufacturer Narrative
H11: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.G3 (date received by manufacturer), g6 type or report - follow up# 2), h2 (correction and additional information), h4 (device manufacturing date is unknown), 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.
Event or Problem Description
It was reported that some foreign material was found in the sterile safety soft tissue biopsy tray.It was further reported that on assessment afterward nursing manager palpated debris and described it as " hard, like cardboard".

• Brand Name: SAFETY SOFT TISSUE BIOPSY TRAY
• Common Device Name: TRAY, SURGICAL, 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: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 22332749
• Report Number: 1625685-2025-00058
• Device Sequence Number: 9017516
• Product Code: FSH
• UDI-Device Identifier: 10885403108549
• UDI-Public: (01)10885403108549
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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 Catalogue Number: 4382SP
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 09/10/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/10/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 114 KG