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

Catalog Number	50-9050A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records has not been performed.The device is not available for return; however, photos were provided for review.Review is underway.The investigation is currently underway.D4 (expiration date is unknown), g4: pma/510(k) #: k201155; k241946, h4 (device manufacturing date is unknown).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 an unknown substance was observed protruding from the site of the peritx abdominal drain device.During follow up it was reported that the treating physician elected to manage the issue with oral antibiotics.The clinician decided to leave the drain in situ, as the patient is currently receiving end of life care and the physician did not want to subject the patient to a removal and reinsertion procedure.The drain remains in situ, and the patient is reported to be stable.
Event or Problem Description
It was reported that an unknown substance was observed protruding from the site of the peritx abdominal drain device.During follow up it was reported that the treating physician elected to manage the issue with oral antibiotics.The clinician decided to leave the drain in situ, as the patient is currently receiving end of life care and the physician did not want to subject the patient to a removal and reinsertion procedure.The drain remains in situ, and the patient is reported to be stable.
Additional Manufacturer Narrative
H11: the physical sample was not returned for evaluation.One photo was provided and reviewed.During photo review, it was observed that the catheter was displaced, with the cuff positioned outside the body.There also appeared to be inflammation in the surrounding area.The underlying cause of these findings cannot be determined from the photo alone.Potential harm associated with cuff dislodgement could be infection.However, we cannot definitively confirm that infection was the result of cuff dislodgement.We are unable to assess whether the issue resulted from insertion technique or product related.The lot number is unknown, so a device history record could not be performed.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.G3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h6 (annex f - health effect - clinical code), 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
• 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): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 24631922
• Report Number: 1423507-2026-00045
• Device Sequence Number: 12974960
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 50-9050A
• Device Lot Number: UNKNOWN
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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