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	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were four peritx peritoneal catheter & starter kits received in pleurx pleural catheter kit boxes and without starter kits.During follow up response it was reported that the issue occurred prior to use, when the product was received.There was no patient involvement.
Additional Manufacturer Narrative
H11cthe lot number for the device was provided.The device history records are currently under review.A photo was provided; photo review is currently underway.The device is pending return.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 there were four peritx peritoneal catheter & starter kits received in pleurx pleural catheter kit boxes and without starter kits.During follow up response it was reported that the issue occurred prior to use, when the product was received.There was no patient involvement.
Additional Manufacturer Narrative
H11: two physical samples were received and evaluated.During visual inspection, it was observed that the incorrect carton had been used.The bottle kits were not included in the return.One photo was provided by the customer and reviewed.During photo review, the photo also verifies the use of the wrong carton.Therefore, the investigation was confirmed for the reported label content incorrect.The issue was traced to a manufacturing issue.A formal investigation was opened to further review these issues.A review of the device history record (dhr) was completed.No confirmed quality issues or rejections related to the reported incident were identified.The review verified that all procedural and functional criteria required for product release were fully satisfied.The complaint was entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis process.D4 (medical device expiration date), d9 (device available for evaluation; received to manufacturer on), h2 (correction, additional information, and device evaluation), h3 (device eval by manufacturer?), h4 (device manufacture date), 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: 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: 23840699
• Report Number: 1423507-2025-00179
• Device Sequence Number: 9526713
• Product Code: PNG
• UDI-Device Identifier: 10885403501838
• UDI-Public: (01)10885403501838(17)270806(10)REKU0292
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 03/05/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown