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

Model Number 50-9050A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2023

Event Type  malfunction  

Event Description

Description of the problem (what / why) - valve leaking.How many times did the defect occur - once.Medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - yes.Safety problem - no.Problem solved - yes.How was the problem solved / additional information - valve change.Photo / sample available - yes.Safety valve broken / damaged / defective - damaged.Safety clamp open if valve broken./ damaged./ d.- no indication / not applicable.Safety valve lug broken / damaged - no indication / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes.Impact on patient - valve change.Contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication of this / not applicable.Time spent in catheter - (b)(6) 2023.Where is the catheter located: in the abdomen or chest? - abdomen.Connected device (pleurx/peritx/brand) - 50-9050a.Procedure performed by - worker.Performed at - home.Additional information - none / not relevant.

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0401.Patient problem code: f26.

Event Description

Description of the problem (what / why) - valve leaking.How many times did the defect occur - once.Medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - yes.Safety problem - no.Problem solved - yes.How was the problem solved / additional information - valve change.Photo / sample available - yes.Safety valve broken / damaged / defective - damaged.Safety clamp open if valve broken./ damaged./ d.- no indication / not applicable.Safety valve lug broken / damaged - no indication / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes.Impact on patient - valve change.Contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication of this / not applicable.Time spent in catheter - 2023-06-20.Where is the catheter located: in the abdomen or chest? - abdomen.Connected device (pleurx/peritx/brand) - 50-9050a.Procedure performed by - worker.Performed at - home.Additional information - none / not relevant.

Manufacturer Narrative

(b)(4) follow-up emdr for device evaluation: one sample was received by our quality team for investigation.Through visual inspection of the valve, no issues with the inner valves were observed.A syringe attached and water was introduced to the valve, at light pressure, no leaking observed; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001420304 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 available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: PERITX PERITONEAL CATHETER MINI KIT
• Type of Device: 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17320729
• MDR Text Key: 319321087
• Report Number: 1625685-2023-00070
• Device Sequence Number: 1
• Product Code: PNG
• UDI-Device Identifier: 10885403500831
• UDI-Public: (01)10885403500831
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

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
• Device Operator: Health Professional
• Device Model Number: 50-9050A
• Device Catalogue Number: 50-9050A
• Device Lot Number: 0001420304
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other