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

Catalog Number	50-7500B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that registered nurse was emptying pleurx drain.Connector "clicked" into position as expected, however upon releasing the roller clamp and beginning to drain, the connector piece of the pleurx drain began to leak and was "sucking" air in addition to pulling pleural fluid.Essentially there was an air leak at the connection site.Rn stopped draining at this time.Patient did not experience any symptoms, however obtained chest xray afterwards to make sure no harm was done.Verbatim.Rcc received complaint via email.Email(s) attached.Registered nurse was emptying pleurx drain.Connector "clicked" into position as expected, however upon releasing the roller clamp and beginning to drain, the connector piece of the pleurx drain began to leak and was "sucking" air in addition to pulling pleural fluid.Essentially there was an air leak at the connection site.Rn stopped draining at this time.Patient did not experience any symptoms, however obtained chest xray afterwards to make sure no harm was done.Per email received on (b)(6) 2023: the leakage occurred between the access tip and the catheter valve, hard to tell which is originated from.No damage noted on access tip and valve.Catheter was located left flank/oblique side.No sample available.No impact to the patient.Chest xray afterwards just for preliminary harm.No harm noted.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0504.Patient problem code: f26.
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.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001519568 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.
Event or Problem Description
It was reported by customer that registered nurse was emptying pleurx drain.Connector "clicked" into position as expected, however upon releasing the roller clamp and beginning to drain, the connector piece of the pleurx drain began to leak and was "sucking" air in addition to pulling pleural fluid.Essentially there was an air leak at the connection site.Rn stopped draining at this time.Patient did not experience any symptoms, however obtained chest xray afterwards to make sure no harm was done.Verbatim rcc received complaint via email.Email(s) attached.Registered nurse was emptying pleurx drain.Connector "clicked" into position as expected, however upon releasing the roller clamp and beginning to drain, the connector piece of the pleurx drain began to leak and was "sucking" air in addition to pulling pleural fluid.Essentially there was an air leak at the connection site.Rn stopped draining at this time.Patient did not experience any symptoms, however obtained chest xray afterwards to make sure no harm was done.Per email received on 11/09/2023: 1.The leakage occurred between the access tip and the catheter valve, hard to tell which is originated from.2.No damage noted on access tip and valve.3.Catheter was located left flank/oblique side.4.No sample available.5.No impact to the patient.Chest xray afterwards just for preliminary harm.No harm noted.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS
• 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: 18187844
• Report Number: 9680904-2023-00040
• Device Sequence Number: 7322219
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: Health Professional
• Device Expiration Date: 11/15/2025
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001519568
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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