MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER KIT; 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	09/29/2022
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).
Event or Problem Description
It was reported by the customer that pleurx catheters tear during the removal of the catheter and the catheter completely ripped apart at the area proximal to the cuff.Verbatim: over the last year we have had more pleurx catheters tear during the removal of the catheter.We have been putting these in for more than 15 years and never had this issue before.Today the catheter completely ripped apart at the area proximal to the cuff.We had to use a scalpel to get the catheter out and then sutures to close up that area.On (b)(6) 2022: the tube is normally very easy to get out.They have become increasingly more fragile and in breaking off more difficult to remove.No photos available.
Event or Problem Description
It was reported by the customer that pleurx catheters tear during the removal of the catheter and the catheter completely ripped apart at the area proximal to the cuff.Verbatim: over the last year we have had more pleurx catheters tear during the removal of the catheter.We have been putting these in for more than 15 years and never had this issue before.Today the catheter completely ripped apart at the area proximal to the cuff.We had to use a scalpel to get the catheter out and then sutures to close up that area.(b)(6) 2022: the tube is normally very easy to get out.They have become increasingly more fragile and in breaking off more difficult to remove.No photos available.
Additional Manufacturer Narrative
Pr 6201343 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 0001461677was 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.As the other lot involved in this incident is unknown, a device history review could not be completed.Based on the available information we are not able to identify a root cause at this time.Awareness training will be performed.A quality notification has been sent to the supplier to make them aware of this failure.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.H3 other text : see manufacture narration.

• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 15595209
• Report Number: 1625685-2022-00092
• Device Sequence Number: 2215422
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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 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: 09/29/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 12/23/2022
• 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