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

Model Number	50-7500B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
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
It was reported by the customer that the tip of the drainage device broke off upon insertion.Verbatim: patient had a pleur-x catheter placed yesterday for malignant effusion.I assessed the catheter this morning and found the insertion site patent.I attempted to access the pleur-x catheter with a standard pleur-x access and drainage kit and the tip of the drainage device broke off immediately upon insertion into the access valve of the pleur-x catheter.The access valve of the pleur-x catheter also became cracked when the tip of the drainage device snapped off.Pleural fluid at this point was beginning to flow freely from the pleur-x catheter, so the blue emergency clamp was placed onto the tubing of the pleur-x and a tegaderm was wrapped around the access valve (the cap cannot be placed on the valve correctly due to the crack in the plastic of the valve).Dr.(b)(6) (the interventional radiologist) who placed the catheter, dr.(b)(6) (my attending physician), the patient and his partner abigail were all made aware of the incident as soon as it occurred.
Event or Problem Description
It was reported by the customer that the tip of the drainage device broke off upon insertion.Verbatim: patient had a pleur-x catheter placed yesterday for malignant effusion.I assessed the catheter this morning and found the insertion site patent.I attempted to access the pleur-x catheter with a standard pleur-x access and drainage kit and the tip of the drainage device broke off immediately upon insertion into the access valve of the pleur-x catheter.The access valve of the pleur-x catheter also became cracked when the tip of the drainage device snapped off.Pleural fluid at this point was beginning to flow freely from the pleur-x catheter, so the blue emergency clamp was placed onto the tubing of the pleur-x and a tegaderm was wrapped around the access valve (the cap cannot be placed on the valve correctly due to the crack in the plastic of the valve).Dr.(b)(6) (the interventional radiologist) who placed the catheter, dr.(b)(6) (my attending physician), the patient and his partner (b)(6) were all made aware of the incident as soon as it occurred.
Additional Manufacturer Narrative
(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.H3 other text : see manufacturer narration.

• 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: 15327036
• Report Number: 9680904-2022-00031
• Device Sequence Number: 6484887
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: 50-7500B
• Device Catalogue Number: 50-7500B
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/19/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown