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

Model Number	50-7700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
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.(b)(4).Follow-up emdr for device evaluation: one photo and one sample were provided to our quality team for investigation.Through visual inspection, it was observed that the polyester cuff is disconnected from the catheter tubing 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 0001430062 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.
Event or Problem Description
It was reported: customer received kit with defective issue; no pt harm.Event description states: disconnected-cuff from catheter 06-may-2022 - per clinician : a patient in our clinic had a pleurx drain placed (b)(6) 2021.When it was removed friday (b)(6) 2022, the cuff was no longer present on the drain.The area under the skin near the insertion site was checked and the cuff could not be found.The patient is following up at the end of may, but he will call if he experiences any symptoms.The area where the cuff was present, there is now a notch and horizontal striations.I was told by a representative, andrew, that i could be shipped a box, so i can send back the pleurx drain for inspection.Per email 09-may-2022 can you please verify the lot number # you provided? we can¿t seem to locate it in our system.Lot no.: 0001430062.Can you please provide the product number? model/cat no.: 50-7700.Would you be able to provide dob and sex of patient? (b)(6) 1947 male.Would you happen to have photos you can share? would you happen to have samples to return? if so, please verify if the product is contaminated.Yes, have catheter in biohazard bag since it was inside the patient.Was the cuff loose or broken? no.Was there any impact to the patient? none at this time.Catheter removed (b)(6) 2022 - has follow up appointment (b)(6) 2022.Is there a photo or sample available showing the reported issue for the evaluation? what is the lot number associated with reported issue? lot number of product above what was done to resolve the issue? patient has follow up appointment.Per the doctor who removed the catheter: "i discussed with thoracic surgery who recommends monitoring.If it becomes irritated or infected, they can i/d.I discussed this with the patient and his wife.".

• Brand Name: PLEURX PLEURAL CATHETER AND STARTER KIT
• Common Device Name: 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: 14437640
• Report Number: 1625685-2022-00054
• Device Sequence Number: 17419962
• Product Code: DWM
• UDI-Device Identifier: 10885403231520
• UDI-Public: (01)10885403231520
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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 Expiration Date: 06/30/2022
• Device Model Number: 50-7700
• Device Catalogue Number: 50-7700
• Device Lot Number: 0001430062
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 47 YR
• Patient Sex: Male