MAUDE Adverse Event Report: CAREFUSION, INC SOFT TISSUE BIOPSY TRAY; Tray, Surgical, Needle

Catalog Number	4382A
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, the soft tissue biopsy product was identified damaged, concealed damaged, and the lot and expiration date are unreadable.No patient injury was reported.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records has not been performed.Photos were not provided for review.The device has not been returned for evaluation.The investigation is currently underway.Upon completion of the investigation, a supplemental report will be filed.D4 (expiration date is unknown).H4 (device manufacturing date is unknown).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: SOFT TISSUE BIOPSY TRAY
• Common Device Name: Tray, Surgical, Needle
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): Bard Reynosa S.A. de C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas OK 88780 ; MX 88780
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 25585842
• Report Number: 1423507-2026-00091
• Device Sequence Number: 14813227
• Product Code: FSH
• UDI-Device Identifier: 10885403108501
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 4382A
• Device Lot Number: RELQ3352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 07/14/2026; 09/14/2026; 09/14/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 08/07/2026; 09/14/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown