MAUDE Adverse Event Report: CAREFUSION, INC PERITX DRAINAGE BAG KIT; PERITONEAL, DRAINAGE CATHETER

Catalog Number	50-9510
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device is not available for 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 by the customer that the peritx drainage bag cap system had a leak, even after tightened the drainage bag continued to leak.It was further reported that the leak occurred from the bottom drainage valve of the peritx bag.
Additional Manufacturer Narrative
H10: manufacturing review: a review of the internal manufacturing device records and raw material history files for the reported lot number 0001597006 was performed and no recorded quality problems or rejections related to this incident were found.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.H10: investigation summary: no photos or samples were received by our quality team for evaluation therefore the reported leak failure mode could not be verified.A probable root cause could not be determined.H10: g4 (date received by manufacturer), g7 (type of report; follow up# 1), h2 (correction, additional information).H11: h6: annex g (component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).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 the customer that the peritx drainage bag cap system had a leak, even after tightened the drainage bag continued to leak.It was further reported that the leak occurred from the bottom drainage valve of the peritx bag.

• Brand Name: PERITX DRAINAGE BAG KIT
• Common Device Name: PERITONEAL, DRAINAGE CATHETER
• 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: 22049098
• Report Number: 9680904-2025-00010
• Device Sequence Number: 18396658
• Product Code: PNG
• UDI-Device Identifier: 10885403222412
• UDI-Public: (01)10885403222412(11)241107(17)291007(10)0001597006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 50-9510
• Device Lot Number: 0001597006
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown