MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7510
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the tip does not fit onto pt drain, has a spike sectioning out the tubing that is used to connect to the pt side of the tubing, and the tubing now has a hole in it.
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 was not returned.The investigation is currently underway.H10: b3: date of event: the date of awareness was entered in the date of event field as the actual date of event is unknown.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.
Additional Manufacturer Narrative
H10: manufacturing review: as lot number was not reported it was not possible to do a review of the device history record which allows us to identify, in case it had happened, any rejected inspections or quality issues during the production of the lot number reported.Therefore, it was not possible to identify any finding.H10: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.Based on the available information we are not able to identify a root cause at this time.Examination of the product involved may provide clarification as to the cause for the reported failure.H10: b5 (describe event or problem), g4 (date received by manufacturer), g7 type or report - follow up# 1), h2 (correction and additional information).H11: h6: annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions), annex g (component code) 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 by customer that the tip does not fit onto pt drain, has a spike sectioning out the tubing that is used to connect to the pt side of the tubing, and the tubing now has a hole in it.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• 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: 22066866
• Report Number: 9680904-2025-00012
• Device Sequence Number: 8766471
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• 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): 06/27/2025

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: 50-7510
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown