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	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: a lot number was provided so a device history record is currently underway.Photos were provided and review is currently pending.H3 (device eval by manufacturer) a device has not been returned.Upon completion of the investigation, a supplemental report will be filed.B3 (date of event) the actual date of event is unknown.The date received by manufacturer (awareness date) was entered into the date of event field.G4: pma/510k: 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 customer ordered item: 50-9900c (peritx product) but received one unit packaged in pleurx boxes.The issue was detected prior to use.There was no patient involvement.Based on the follow-up, it was further reported that the product inside the packaging is the correct peritx peritoneal catheter kit, and only the outer box is incorrect.
Additional Manufacturer Narrative
H11: two photos sample were provided to our quality team for evaluation.We can confirm that the incorrect carton is present.The product was packaged into the incorrect carton; therefore, the reported failure mode was confirmed.In one photo, what appears to be the correct cartoon can be seen with a different lot number.(additional photos that would include the carton labeling would be needed to definitively confirm).A review of the internal manufacturing device records and raw material history files for the reported lot number reku0292 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.Based on the quality team's investigation, it was identified that the probable root cause is traced to manufacturing related.A formal investigation was opened to further investigate these defects.The complaint has been logged in the complaint management system and will be monitored through tracking, trending, and quality data analysis for potential future occurrences.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.
Event or Problem Description
It was reported that the customer ordered item 50-9900c (peritx product), but received one unit packaged in pleurx boxes.The issue was detected prior to use.There was no patient involvement.Based on the follow-up, it was further reported that the product inside the packaging is the correct peritx peritoneal catheter kit, and only the outer box is incorrect.

• 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: 23219102
• Report Number: 1423507-2025-00072
• Device Sequence Number: 13219040
• Product Code: PNG
• UDI-Device Identifier: 10885403501838
• UDI-Public: (01)10885403501838(17)270731(10)REKU0292
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/05/2026

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: Health Professional
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown