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

Model Number	50-7000B
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
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.(b)(4).
Event or Problem Description
I was reported that valve on tubing may be defective - not clicking in place.Verbatim: ".I have a different issue that i want to report.Third case now: i have noticed that drainage kit included in pleurx kit does not click with pleurx tubing.This looks like a manufacturing problem.We have been using separate pleurx drain bottles to drain kit.Cap still goes on nicely but connection kit does not.Have you heard this from other physicians or i am the only anomaly here? ".
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
I was reported that valve on tubing may be defective - not clicking in place."i have a different issue that i want to report.Third case now : i have noticed that drainage kit included in pleurx kit does not click with pleurx tubing.This looks like a manufacturing problem.We have been using separate pleurx drain bottles to drain kit.Cap still goes on nicely but connection kit does not.Have you heard this from other physicians or i am the only anomaly here?".

• Brand Name: PLEURX PLEURAL CATHETER 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: 14515814
• Report Number: 1625685-2022-00061
• Device Sequence Number: 15112087
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 06/14/2022

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 Model Number: 50-7000B
• Device Catalogue Number: 50-7000B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/14/2022
• 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
• Patient Sex: Unknown