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

Catalog Number	4380
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the lot number was provided, so a device history record review is currently underway.The investigation is currently underway.H3 (device eval by manufacturer) a device has not been returned.Upon completion of the investigation, a 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.
Event or Problem Description
It was reported that as the health care provider (hcp) went to re-cap the scalpel obtained from the economy soft tissue biopsy tray, the hcp experienced a finger cut; therefore, the hcp applied a bandage, and the issue was considered resolved as no further care was necessary nor was it requested by the hcp.The patient reportedly did not have any infectious diseases and was treated without any difficulties and no other workflow interruptions happened after the incident.
Event or Problem Description
It was reported that as the health care provider (hcp) went to re-cap the scalpel obtained from the economy soft tissue biopsy tray, the hcp experienced a finger cut; therefore, the hcp applied a bandage, and the issue was considered resolved as no further care was necessary nor was it requested by the hcp.The patient reportedly did not have any infectious diseases and was treated without any difficulties and no other workflow interruptions happened after the incident.
Additional Manufacturer Narrative
H11: there were no photos provided for review, and the physical sample was not received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.The device history record dhr was reviewed, and no deviations/issues were identified or associated with the reported event regarding product materials or during manufacturing, packaging or qc inspection process.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.The lot met all release criteria.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.Complaints received for this product and conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for the identification of emerging trends.D3 (medical device manufacturer), g1 (manufacturing location), g3 (date received by manufacturer), g4 (is combination product?), 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).Initial mdr mfr report # 1625685-2025-00077, site legal name (fda) reported, carefusion 2200, inc.- mannford, ok / 74044; site registration number (fda) 1625685.Correct site legal name (fda) is, vernon hills; site registration number (fda) 1423507.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: ECONOMY 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: 22691623
• Report Number: 1625685-2025-00077
• Device Sequence Number: 8306852
• Product Code: FSH
• UDI-Device Identifier: 10885403108563
• UDI-Public: (01)10885403108563(17)270131(10)REKQ1420
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4380
• Device Lot Number: REKQ1420
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2025
• 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: Female