MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER MINI KIT; APPARATUS, SUCTION, PATIENT CARE

Model Number 50-7050

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

Description of the problem (what / why) - valve damaged 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 - no 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 - since 2023-02-13 where is the catheter located: in the abdomen or chest? - abdomen connected device (pleurx/peritx/brand) - 50-7050.Procedure performed by - employees performed at - not known additional information - none / not relevant.

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.

Manufacturer Narrative

(b)(4)follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, it was observed that the inner valves were missing; therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001471896 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.Manufacturing personnel have been notified of this incident and awareness training was provided.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

(b)(6)2023: could we please ask the customer to elaborate on the valve being damaged? was it cracked/broken? was there leakage? -> we don¿t know if the valve has been broken or damaged.It was leaking.Description of the problem (what / why) - valve damaged 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 - no 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 - since (b)(6)2023 where is the catheter located: in the abdomen or chest? - abdomen connected device (pleurx/peritx/brand) - 50-7050.Procedure performed by - employees performed at - not known 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.Upon visual inspection of the sample, it was observed that the inner valves were missing; therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001471896 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.Manufacturing personnel have been notified of this incident and awareness training was provided.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

21 march 2023: could we please ask the customer to elaborate on the valve being damaged? was it cracked/broken? was there leakage? -> we don¿t know if the valve has been broken or damaged.It was leaking.Description of the problem (what / why) - valve damaged.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 - no.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 - since (b)(6) 2023.Where is the catheter located: in the abdomen or chest? - abdomen.Connected device (pleurx/peritx/brand) - 50-7050.Procedure performed by - employees.Performed at - not known.Additional information - none / not relevant.

• Brand Name: PLEURX PLEURAL CATHETER MINI KIT
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• 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: 16612886
• MDR Text Key: 312337328
• Report Number: 1625685-2023-00033
• Device Sequence Number: 1
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141965
• 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,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 50-7050
• Device Catalogue Number: 50-7050
• Device Lot Number: 0001471896
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1