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

Model Number	50-7000B
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported by customer that catheter popped off during flush.Verbatim: attempting to de-clog patient's existing pleurx catheter by flushing with sterile water through a connected pleurx lockable drainage line and the connector on the pleurx catheter popped off during flush.Slide clamp from lockable drainage line kit immediately applied.Thoracentesis then performed for patient to drain pleural effusion and pleurx catheter was removed.What was the original intended procedure? : attempting to de-clog patients existing pleurx catheter by flushing with sterile water.What was the impact to the patient? no.Where is the catheter located? discarded.Was the pleurx catheter occluded? attempt was made to irrigate the catheter for possible tpa.This is when the valve came completely off the tubing.Was the clamp open during the reported issue " disconnected catheter valve from the catheter? the clamp was not on the catheter during these attempts.
Event or Problem Description
It was reported by customer that catheter popped off during flush.Attempting to de-clog patient's existing pleurx catheter by flushing with sterile water through a connected pleurx lockable drainage line and the connector on the pleurx catheter popped off during flush.Slide clamp from lockable drainage line kit immediately applied.Thoracentesis then performed for patient to drain pleural effusion and pleurx catheter was removed.What was the original intended procedure?: attempting to de-clog patients existing pleurx catheter by flushing with sterile water.What was the impact to the patient? no.Where is the catheter located? discarded.Was the pleurx catheter occluded? attempt was made to irrigate the catheter for possible tpa.This is when the valve came completely off the tubing.Was the clamp open during the reported issue " disconnected catheter valve from the catheter? the clamp was not on the catheter during these attempts.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001441804 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: PLEURX PLEURAL CATHETER 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: 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14458641
• Report Number: 1625685-2022-00058
• Device Sequence Number: 4482546
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 50-7000B
• Device Catalogue Number: 50-7000B
• Device Lot Number: 0001441804
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/13/2022
• 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