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

Catalog Number	50-7000B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that what he described as a product failure.He reports that a patient came into the operating room on 11/3 for the inspection of a clogged pleurx catheter.While the physician attempted to change out the catheter, the catheter broke, and 6 inches of the line remained in the patient.As a result, surgery was requested, and the patient had a procedure to remove the remaining portion of the catheter.The customer reports that they still have the piece that broke off in the patient.The catheter was originally inserted on sept 20th of 2023.Verbatim rcc received a complaint via email.Email(s) attached.Inquiry via sharieka hight.Customer is reporting what he described as a product failure.He reports that a patient came into the ir on 11/3 for the inspection of a clogged pleurx catheter.While the physician attempted to change out the catheter, the catheter broke and 6 inches of the line remained in the patient.As a result surgery was requested and the patient had a procedure to remove the remaining portion of the catheter.The customer reports that they still have the piece that broke off in the patient.The catheter was originally inserted on sept 20th of 2023.Customer response 11/08/2023: there was no harm done to the patient.Patient tolerated the procedure well.Surgeon made a small incision so the interventional radiologist could retrieve the piece that was inside the patient.The lot number is as follows: 0001527783.I don¿t see any visible damage to the catheter.Thank you for the follow up.Please keep us in the loop with your findings.Per customer's response 11/09/2023: the catheter was draining slowly, the fluid draining from it appeared to be frank red blood.It was changed for suspicion of it being partially clogged/not draining properly.There was no damage observed or noted to catheter prior to removal.The catheter was not cut during removal.Catheter was broke internal to the body.We still have the piece that broke off in a container.The lot number is: 0001527783.The catheter was is the chest.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0401, patient problem code: f1903.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one physical sample was received by our quality team for investigation.The returned sample had been used and was a biohazard, it was not labeled as a class a or b biohazard.Due to safety concerns, and per our procedures we are unable to evaluate the sample; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001527783 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.The tensile and elongation testing results performed by the supplier were passing, no issues were identified.In addition, about the torn catheter, we are unable to confirm the method of removal.Per the instructions the proper method for removal is - "catheter removal procedure - step 5.Using forceps, dissect around the cuff to free it from the ingrowth.Ensure that the cuff is completely free within the tunnel.6.Grasp the catheter in one hand and pull with a firm, constant pressure." 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
It was reported by customer that what he described as a product failure.He reports that a patient came into the ir on 11/3 for the inspection of a clogged pleurx catheter.While the physician attempted to change out the catheter, the catheter broke, and 6 inches of the line remained in the patient.As a result, surgery was requested, and the patient had a procedure to remove the remaining portion of the catheter.The customer reports that they still have the piece that broke off in the patient.The catheter was originally inserted on (b)(6) 2023.Verbatim: rcc received a complaint via email.Email(s) attached.Inquiry via sharieka hight.Customer is reporting what he described as a product failure.He reports that a patient came into the ir on 11/3 for the inspection of a clogged pleurx catheter.While the physician attempted to change out the catheter, the catheter broke and 6 inches of the line remained in the patient.As a result surgery was requested and the patient had a procedure to remove the remaining portion of the catheter.The customer reports that they still have the piece that broke off in the patient.The catheter was originally inserted on (b)(6) 2023.Customer response 11/08/2023: there was no harm done to the patient.Patient tolerated the procedure well.Surgeon made a small incision so the interventional radiologist could retrieve the piece that was inside the patient.The lot number is as follows: 0001527783.I don¿t see any visible damage to the catheter.Thank you for the follow up.Please keep us in the loop with your findings.Per customer's response 11/09/2023: the catheter was draining slowly, the fluid draining from it appeared to be frank red blood.It was changed for suspicion of it being partially clogged/not draining properly.There was no damage observed or noted to catheter prior to removal.The catheter was not cut during removal.Catheter was broke internal to the body.We still have the piece that broke off in a container.The lot number is: 0001527783.The catheter was is the chest.

• 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: 18186724
• Report Number: 1625685-2023-00117
• Device Sequence Number: 15263388
• Product Code: DWM
• UDI-Device Identifier: 10885403075971
• UDI-Public: (01)10885403075971
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 50-7000B
• Device Lot Number: 0001527783
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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