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

Catalog Number	50-9050A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0401.Patient problem code: f24.H10 : d4 (expiration date: 01/2027).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
Pleurx safety valve was not working its got damage after placement.On (b)(6) 2024- received an email response from complainant for information requested.Refer email attached.(b)(6).Patient condition was not good at present as i discussed with kol.When hi inserted the catheter drainage properly.On (b)(6) 2024- received an email response from complainant for information requested.Current patient condition is not good.Hi is serious after pleurx placement.Our consult is very annoyed.
Additional Manufacturer Narrative
H10: pr (b)(4) follow-up emdr for device evaluation: a lot was provided, and a dhr review was performed.As a result of the dhr review no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.A sample was unavailable for analysis.We are unable to confirm a failure or identify a root cause.We are unable to confirm any failure that contributed to the adverse event.The complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process.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
Pleurx safety valve was not working its got damage after placement 04-oct-2024- received an email response from complainant for information requested.Refer email attached.Shaik khashifa samrin.Patient condition was not good at present as i discussed with kol.When hi inserted the catheter drainage properly.03-oct-2024- received an email response from complainant for information requested.Answers added in follow up tab.Refer email attached.Shaik khashifa samrin current patient condition is not good.Hi is serious after pleurx placement.Our consult is very annoyed.

• Brand Name: PERITX PERITONEAL CATHETER MINI KIT
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• 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: 20453795
• Report Number: 1625685-2024-00112
• Device Sequence Number: 9232226
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831(11)230920(17)270131(10)0001534421
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K201155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 50-9050A
• Device Lot Number: 0001534421
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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