MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PERITONEAL CATHETER MINI KIT; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-9050
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that air and fluid have been leaking both in and out of the connection hub while draining.From customer's report: fluid leak out of connecting tubing luer end - also air leaked into tubes - bubbles noted in tubing of fluid.The luer end was connected to 3-way tap to drain fluid prior to capping tubing.During drainage leaking noted.Multiple 3-way taps and bungs aseptically changes to attempt to resolve leak.Visually could be seen fluid leaking from the luer/thread of connecting tubing and air entry at that site.No adverse patient outcome.Photo review by rcc - bubbles noted in the tubing.
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.
Event or Problem Description
It was reported that air and fluid have been leaking both in and out of the connection hub while draining.From customer's report: fluid leak out of connecting tubing luer end - also air leaked into tubes - bubbles noted in tubing of fluid.The luer end was connected to 3-way tap to drain fluid prior to capping tubing.During drainage leaking noted.Multiple 3-way taps and bungs aseptically changes to attempt to resolve leak.Visually could be seen fluid leaking from the luer/thread of connecting tubing and air entry at that site.No adverse patient outcome.Photo review by rcc - bubbles noted in the tubing.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one photo and one sample were received by our quality team for investigation.The drainage line was observed by the mannford site and the supplier.No issues with the drainage line and to the luer connection were observed.A failure could not be replicated.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001414958 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.Manufacturing personnel have been notified of this incident and awareness training was provided.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.H3 other text : see manufacture narration.

• Brand Name: PLEURX PERITONEAL CATHETER MINI KIT
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 16433610
• Report Number: 1625685-2023-00026
• Device Sequence Number: 3136453
• Product Code: DWM
• UDI-Device Identifier: 50885403075962
• UDI-Public: (01)50885403075962
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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 Catalogue Number: 50-9050
• Device Lot Number: 0001414958
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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