MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7510
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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.Device problem code: a0201 patient problem code: f26 h3 other text : see manufacture narration.
Event or Problem Description
It was reported: customer received kit with defective issue; no pt harm rcc received a complaint via email.Email(s) attached.Called customer on (b)(6) 2024, in addition, the alcohols wipes have been found dry.Sometime in october last year, (no specific date) and issue was not reported to edgepark,.
Additional Manufacturer Narrative
(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, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.We would be very interested in examining product that does not meet your expectations and our quality standards.A photo of the defect could assist our quality team in their investigation.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported: customer received kit with defective issue; no pt harm rcc received a complaint via email.Email(s) attached.Called customer on (b)(6) 2024, in addition, the alcohols wipes have been found dry.Sometime in october last year, (no specific date) and issue was not reported to (b)(6).

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 19193740
• Report Number: 9680904-2024-00007
• Device Sequence Number: 12667567
• Product Code: DWM
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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 Catalogue Number: 50-7510
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/21/2024
• 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: Other
• Patient Sex: Unknown