MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 500ML 10/CS - 50-7500B; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7500B
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: customer received kit with defective issue; no pt harm.Event description states: bottles were open in box.On (b)(6) 2023: customer state that initially confirmed that call was about insurance coverage.Customer said that the bottles were not sealed in packaging when she went to use them.However, was able to drain successfully with another bottle and ep did replace bottles, didn't remember the exact number that were not packaged correctly.How many bottles were non-usable: happened twice for two different shipments.No damage to shipping box.No damage to inside box.Discarded bottles.Did not record the lot number.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a020503.Patient problem code: (b)(6).
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.H3 other text: see manufacture narration.
Event or Problem Description
It was reported: customer received kit with defective issue; no pt harm.Event description states: bottles were open in box.Questions/inquiries: confirm patient harm and notate in event desc per attached statement above.On 11jan2023: customer state that initially confirmed that call was about insurance coverage.Customer said that the bottles were not sealed in packaging when she went to use them.However, was able to drain successfully with another bottle and ep did replace bottles, didn't remember the exact number that were not packaged correctly.How many bottles were non-usable: happend twice for two different shipments.No damage to shipping box.No damage to inside box discarded bottles.Did not record the lot number.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS - 50-7500B
• 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: 16158945
• Report Number: 9680904-2023-00002
• Device Sequence Number: 6977809
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K971753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 50-7500B
• Device Catalogue Number: 50-7500B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 01/30/2023
• 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