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

Catalog Number	50-7500B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
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: a050401.Patient problem code: f26.
Event or Problem Description
Leaky connection between pleurx catheter valve and bottle access tip.When it started to drain, the connection between the pleurx catheter valve and bottle access tip was leaking.A new bottle was used and the issue was resolved.07-may-2024 - received an email response from complainant for information.Answers added in follow up tab.(b)(6) happened to the same patient on 1 occasion.Where did leakage occurred? from the access tip and the catheter valve.Is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? yes, according to the customer.Did the leakage occurred to the drainage line to the bottle? do you mean to say that the leakage was from the line? was there damage noted on the access tip or patient's valve.No.Not at the entry point.Where is the catheter located? chest.What was the impact to the patient? patient was distressed.How was the issue resolved? a new bottle was used.The pleurx drain was accessed with pleurx bottle, which then proceeded to leak.I disconnected the drain and attached another pleurx bottle, and drained without incident 400mls.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: three photo samples were provided to our quality team for investigation.Upon visual inspection of the photos, bottle was observed in good conditions with a correct connection of the drainage line and little drops of liquid were observed coming out from the access tip.Based on provided pictures, the reported failure mode leakage was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001527680 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
Leaky connection between pleurx catheter valve and bottle access tip.When it started to drain, the connection between the pleurx catheter valve and bottle access tip was leaking.A new bottle was used and the issue was resolved.07-may-2024 - received an email response from complainant for information.Answers added in follow up tab.Refer email attached.(b)(6) (b)(4) happened to the same patient on 1 occasion.-where did leakage occurred? from the access tip and the catheter valve - is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked in to the valve? yes, according to the customer.- did the leakage occurred to the drainage line to the bottle? do you mean to say that the leakage was from the line? - was there damage noted on the access tip or patient's valve.No.Not at the entry point.- where is the catheter located? chest.- what was the impact to the patient? patient was distressed.- how was the issue resolved? a new bottle was used.- could you please provide a further description of the issue " it appears piece had come off the drain itself and the new cap has nothing to grip to" the catheter valve wing/locking tab seems to be broken.- what piece customer is referring about? is it for disconnected support clip? yes.- was there issue with the catheter valve? broken locking tab? the catheter valve wing/locking tab seems to be broken.- was there issue connecting valve cap to the catheter valve due to broken locking tab? the cap cannot be secured.The customer used a tape to secure the cap.- if yes, please provide lot number and material number associated with pleurx catheter.The customer is still looking for the information.- how was the issue resolved? the customer used a tape to secure the cap.The pleurx drain was accessed with pleurx bottle, which then proceeded to leak.I disconnected the drain and attached another pleurx bottle and drained without incident 400mls.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS-50
• 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: 19287612
• Report Number: 9680904-2024-00009
• Device Sequence Number: 12597425
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/03/2024

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: Health Professional
• Device Expiration Date: 01/16/2026
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001527680
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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