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	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Product possibly involved in injury: no.Complaint: patient has connected a reservoir with a valve, fluid leaked at the connection point.They connected another reservoir and everything was tight.Additionally affected lot no.: 0001496988.Additional information: description of issue (what / why): patient has connected a reservoir with a valve, fluid leaked at the connection point.They connected another reservoir and everything was tight.How often occured defect: once.Medical intervention (other than first aid): no.Needle/probe stick: no.Other actions taken: no.Safety issue: no.Issue resolved: yes.How issue resolved / additional information: replacement.Photo / sample available: no.Safety valve broken / damaged / disconnected: no.Safety clamp open, when valve broke/damaged/disconnected: no.Safety valve nose broken / damaged: no.Locking tab broken / damaged: no.Leakage: no.Successful drainage: yes.Impact to patient: had to use another bottle.Exposure to blood / bodily fluid: no.Course of treatment changed due to event: no.Time catheter in place: 16.08.2023.Connected device (pleurx/peritx/brand) 50-7500b.Procedure performed by: end user / lay person.Procedure performed at: home.Additional information: the pallets are loaded / stored in the same way as bd delivers them.No pallets are stacked.We do not know how the bottles are stored at the patient.Information on the error pattern: fault location: insertion pin.Type of defect: damaged (broken, brittle, deformed).Fault location: insertion pin.Type of error: damaged (broken, brittle, deformed).Response received on 04/dec/2023.Where did leakage occur? - fluid leaked at the connection point.Is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked into the valve? - yes.Did the leakage occur to the drainage line to the bottle? - not known.Was there damage noted on the access tip or patient's valve.- no.Where is the catheter located? - chest.
Additional Manufacturer Narrative
Pr (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 0001496988 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
Violation (patient / other): no.Product possibly involved in injury: no.Product available for examination: no.Detection site: 2 - on application.Origin: patient.Complaint: patient has connected a reservoir with a valve, fluid leaked at the connection point.They connected another reservoir and everything was tight.Product information: item no.: 50-7500b/v001 - pleurx¿ drainage set, 500 ml reservoir incl.Accessories pu (packaging unit) (b)(4) pieces.Additionally affected item no.: 50-7500b/v001 - pleurx¿ drainage set, 500 ml reservoir incl.Accessories pu (packaging unit) (b)(4) pieces.Additionally affected lot no.: 0001496988.Additional information: description of issue (what / why): patient has connected a reservoir with a valve, fluid leaked at the connection point.They connected another reservoir and everything was tight.How often occured defect: once.Medical intervention (other than first aid): no.Needle/probe stick: no.Other actions taken: no.Safety issue: no.Issue resolved: yes.How issue resolved / additional information: replacement.Photo / sample available: no.Safety valve broken / damaged / disconnected: no.Safety clamp open, when valve broke/damaged/disconnected: no.Safety valve nose broken / damaged: no.Locking tab broken / damaged: no.Leakage: no.Successful drainage: yes.Impact to patient: had to use another bottle.Exposure to blood / bodily fluid: no.Course of treatment changed due to event: no.Time catheter in place: (b)(6) 2023.Connected device (pleurx/peritx/brand) 50-7500b.Procedure performed by: end user / lay person.Procedure performed at: home.Replacement requested: no.Credit requested: yes.Additional information: the pallets are loaded / stored in the same way as bd delivers them.No pallets are stacked.We do not know how the bottles are stored at the patient.Information on the error pattern: fault location: insertion pin.Type of defect: damaged (broken, brittle, deformed).Fault location: insertion pin.Type of error: damaged (broken, brittle, deformed).Response received on 04/dec/2023.Where did leakage occur? - fluid leaked at the connection point is this at the access tip and the catheters valve? if it at the access tip did the access tip fully clicked into the valve? - yes.Did the leakage occur to the drainage line to the bottle? - not known.Was there damage noted on the access tip or patient's valve.- no.Where is the catheter located? - chest.

• 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: 18267154
• Report Number: 9680904-2023-00041
• Device Sequence Number: 7900175
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/26/2024

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: 05/09/2025
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001496988
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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