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

Catalog Number	50-7700
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that cuff of pleurx is out of skin.Verbatim: cuff of oleurax is out of skin; patient doesn¿t have explanation; exchanging catheter to reduce risk of infection opportunity; no infection reported as of now.Customer response on dec 18, 2024: 1.Was there any medical intervention required including diagnostics, procedures, and treatment? an assessment was done using imaging to determine potential misplacement of catheter/occlusion.2.How was the issue resolved? i was told the intended plan was to replace the pleurx.3.Was catheter replacement necessary due to a loose cuff? the replacement was out of caution to minimize infection risk.4.How was the issue resolved? plan mentioned was to replace pleurx catheter.5.What was the impact to the patient? replacement of new pleurx.6.What is the lot number and material number associated with the reported issue? unk.7.How long has the catheter been in place? no specific time reported but not he patients first pleurx and was shared it was not placed for long.8.Where is the catheter located? abdomen or chest? chest.9.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label?.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a010402, patient problem code: f1905.H10: as the lot number for the device was not provided, a review of the device history records has not been performed.The device was not returned.The investigation is currently underway.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H10: manufacturing review: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, it was observed that the part of the cuff is exposed.We cannot confirm a device failure and are unable to make any further observations.A device history record could not be evaluated as the lot number is unknown.Unable to establish a potential cause without additional information or physical sample.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by customer that cuff of pleurx is out of skin.Verbatim: - cuff of oleurax is out of skin.- patient doesn¿t have explanation.- exchanging catheter to reduce risk of infection opportunity.- no infection reported as of now.Customer response on (b)(6) 2024.1.Was there any medical intervention required including diagnostics, procedures, and treatment? an assessment was done using imaging to determine potential misplacement of catheter/occlusion.2.How was the issue resolved? i was told the intended plan was to replace the pleurx.3.Was catheter replacement necessary due to a loose cuff? the replacement was out of caution to minimize infection risk.4.How was the issue resolved? plan mentioned was to replace pleurx catheter.5.What was the impact to the patient? replacement of new pleurx.6.What is the lot number and material number associated with the reported issue? unk.7.How long has the catheter been in place? no specific time reported but not he patients first pleurx and was shared it was not placed for long.8.Where is the catheter located? abdomen or chest chest.9.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label?.

• 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 21009619
• Report Number: 1625685-2024-00152
• Device Sequence Number: 18225184
• Product Code: DWM
• UDI-Device Identifier: 10885403231520
• UDI-Public: (01)10885403231520
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50-7700
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/24/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown