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 Crack (1135)

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

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0404.Patient problem code: f26.

Event Description

Description of issue (what / why) - crack in the tube.How often occured defekt - ones medical intervention (other than first aid) -not needed needle/probe stick - not needed other actions taken - no safety issue - no issue resolved - yes how issue resolved / additional information - valve change photo / sample avaibale - currently still being checked safety valve broken / damaged / disconnested - no indication for that / not applicable safety clamp open, when valve brok./ damag./ d.- not applicable safety valve nose broken / damaged - no indication for that / not applicable locking tab broken / damaged - no indication for that / not applicable leakage - no indication for that / not applicable successful drainage - yes impact to patient - valve change eyposure to blood / bodily fluid - no indication for that / not applicable course of treatment changed due to event - no indication for that / not applicable connected device (pleurx/peritx/brand) - 50-9050a procedure performed by - worker procedure performed at - home additional information - none / not relevant - was the cracked noticed on patient's catheter? - yes, near the valve - was the cracked noticed on the drainage line which is attached to pleurx bottle? - no - per provided information issue was resolved by changing the valve, so does crack noticed on patient's valve.- crack was in the catheter tube near the valve.The tube was shortened a little and a new valve was attached.

Manufacturer Narrative

Pr (b)(4) follow-up emdr for device evaluation: one sample was received by our quality team for investigation.Through visual inspection of the catheter, crack in the tubing observed.The crack is on the barium stripe and was located in a spot that was able to be cut and a new valve replaced; therefore, the reported failure mode was confirmed.A device history record could not be evaluated as the lot number is unknown.We are unable to determine when or how the crack in the tubing occurred.Based on the available information we are not able to identify a root cause at this time.Manufacturing personnel have been notified of this incident and awareness training will be provided.A quality notification will be sent to the supplier to raise awareness, as we cannot confirm definitively that this was a supplier defect.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.

Event Description

Description of issue (what / why) - crack in the tube.How often occured defekt - ones medical intervention (other than first aid) -not needed needle/probe stick - not needed other actions taken - no safety issue - no issue resolved - yes how issue resolved / additional information - valve change photo / sample avaibale - currently still being checked safety valve broken / damaged / disconnested - no indication for that / not applicable safety clamp open, when valve brok./ damag./ d.- not applicable safety valve nose broken / damaged - no indication for that / not applicable locking tab broken / damaged - no indication for that / not applicable leakage - no indication for that / not applicable successful drainage - yes impact to patient - valve change eyposure to blood / bodily fluid - no indication for that / not applicable course of treatment changed due to event - no indication for that / not applicable connected device (pleurx/peritx/brand) - 50-9050a procedure performed by - worker procedure performed at - home additional information - none / not relevant - was the cracked noticed on patient's catheter? - yes, near the valve - was the cracked noticed on the drainage line which is attached to pleurx bottle? - no - per provided information issue was resolved by changing the valve, so does crack noticed on patient's valve.- crack was in the catheter tube near the valve.The tube was shortened a little and a new valve was attached.

• 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: 17358162
• MDR Text Key: 319963092
• Report Number: 1625685-2023-00071
• 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: 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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other