MAUDE Adverse Event Report: CAREFUSION, INC PERITX PERITONEAL CATHETER & STARTER KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	50-9900C
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.The device has not been returned; however, photos were provided and photo review is pending.The investigation is currently underway.Upon completion of the investigation, a supplemental report will be filed.G4: pma / 510(k)#: k201155; 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 the peritx item came packaged in a pleurx box.There was no patient involvement.
Event or Problem Description
It was reported that the peritx item came packaged in a pleurx box.There was no patient involvement.
Additional Manufacturer Narrative
H11: the physical sample was not received by the quality team; however, three photos were provided for analysis.Review of the photos identified that the product kit tray was packaged in an incorrect product carton, confirming the reported issue.The issue was attributed to a manufacturing-related error, and a corrective action project was initiated to further investigate.A device history record (dhr) review was completed, which identified no quality issues or rejections associated with the reported event.The review confirmed that all procedural and functional release requirements were met.However, the dhr review noted multiple complaints associated with the same lot number.This complaint has been entered into the complaint management system and will be tracked and trended for future occurrences and further evaluated through the quality data analysis process.D4 (medical device expiration date), d4 (unique identifier (udi) #), h4: device manufacture date, g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information).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: PERITX PERITONEAL CATHETER & STARTER KIT
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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 88780 ; MX 88780
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 24765533
• Report Number: 1423507-2026-00056
• Device Sequence Number: 18466396
• Product Code: PNG
• UDI-Device Identifier: 10885403501838
• UDI-Public: (01)10885403501838(17)270731(10)REKU0292
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11.
• 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): 06/08/2026

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: 50-9900C
• Device Lot Number: REKU0292
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown