MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER KIT - 50-7000B; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7000B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional 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: (b)(6).(b)(6) follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see manufacture narration.
Event or Problem Description
It was reported by the customer that valve is cracked on catheter.Verbatim: tm states she just received a call from a customer stating they have a patient with a cracked end valve on their pleurx catheter.(b)(6) 2023: this is not a quality issue apparently the patient broke the valve, it wasn¿t a product malfunction.Please disregard.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see manufacture narration.
Event or Problem Description
It was reported by the customer that valve is cracked on catheter.Verbatim: tm states she just received a call from a customer stating they have a patient with a cracked end valve on their pleurx catheter.05-jan-2023: this is not a quality issue apparently the patient broke the valve, it wasn¿t a product malfunction.Please disregard.Additional information received 19-jan-2023 ¿ what is the date of event? (b)(6) 2023 ¿ what is the mat and lot number? 50-7000b ¿ no lot info ¿ was the issue noticed before or during use? during while cap was being put on, just a chipped tip not a broken valve ¿ was there any patient harm/impact? if so was there a need for any medical treatment or intervention? no harm ¿ was there leakage noticed at the catheter valve? no ¿ where is the catheter located? abdomen or chest left chest ¿ how long has the catheter been in place ¿ not sure ¿ how was the issue resolved? replacement valve ¿ what is the full name and address of the facility for where the issue occurred? omitted ¿ do you have any photos to show the reported issue? no ¿ do you have a sample to send in for evaluation? no.

• Brand Name: PLEURX PLEURAL CATHETER KIT - 50-7000B
• 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: 16194726
• Report Number: 1625685-2023-00004
• Device Sequence Number: 11833613
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 50-7000B
• Device Catalogue Number: 50-7000B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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