MAUDE Adverse Event Report: CAREFUSION, INC VALVE CAP; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7235A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the inspection of imports, one packaging was found with the product inside but with the packaging open and with no indication that it had ever been sealed.During follow up response it was further reported that the issue was identified upon receiving the products.There was no patient involvement in this case.
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.The device is pending return.Photos were provided and review is underway.The investigation is currently underway.Upon completion of the investigation, a supplemental report will be filed.D2b: pro codes: dwm; png.G4: pma / 510(k)#: k160450; k241946.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 during the inspection of imports, one packaging was found with the product inside but with the packaging open and with no indication that it had ever been sealed.During follow up response it was further reported that the issue was identified upon receiving the products.There was no patient involvement in this case.
Additional Manufacturer Narrative
H11: a review of the internal manufacturing device record and raw material history files for the reported lot number was performed and 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.A physical sample was not received for evaluation, but seven photographs were received and reviewed.During photo review, a second pouch contained the product; however, the packaging was open, and based on image review, no sealing marks were evident along the pouch edge.The observed failure mode has been confirmed as a seal integrity failure.A formal investigation was opened to further investigate these defects to enhance process robustness and prevent recurrence.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: VALVE CAP
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 23479825
• Report Number: 1423507-2025-00130
• Device Sequence Number: 16091675
• Product Code: DWM
• UDI-Device Identifier: 10885403502378
• UDI-Public: (01)10885403502378(17)300503(10)0001624837
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/23/2026

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: Other
• Device Catalogue Number: 50-7235A
• Device Lot Number: 0001624837
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown