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

Model Number	50-7700
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that expired product.Question: rep called and stated she received a call from /omit/ at (b)(6) memorial about a physician placing an expired pleurx.The product expired on 12/31/2021 but she has no other information from the customer.Please contact /omit/ for all information.Response: explained the case needed to be reported to field assurance.Bard/bd cannot recommend placing any product past the labeled expiration date.We have no specific information or testing on use of an expired products.We consider the kit contents to be sterile as long as the packaging is intact with no signs of damage.The physician will have to determine risk vs benefits of leaving the product in the patient.Par was set too high for clinical need.Overstock area designated with overstock supply.Supply chain staff pulled from overstock pallet to replenish department.Staff pulled expired product.Expired product was placed in patient.Physicians stated the patient¿s condition would not be suitable for an exchange.Decision was made to leave expired catheter in place.Supply chain notified of expired product in department.Expired product was pulled the same day.Internal incident report was created.Bd notified.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that expired product.Question: rep called and stated she received a call from /omit/ at north western memorial about a physician placing an expired pleurx.The product expired on 12/31/2021 but she has no other information from the customer.Please contact /omit/ for all information.Response: explained the case needed to be reported to field assurance.Bard/bd cannot recommend placing any product past the labeled expiration date.We have no specific information or testing on use of an expired products.We consider the kit contents to be sterile as long as the packaging is intact with no signs of damage.The physician will have to determine risk vs benefits of leaving the product in the patient.Par was set too high for clinical need.Overstock area designated with overstock supply.Supply chain staff pulled from overstock pallet to replenish department.Staff pulled expired product.Expired product was placed in patient.Physicians stated the patient¿s condition would not be suitable for an exchange.Decision was made to leave expired catheter in place.Supply chain notified of expired product in department.Expired product was pulled the same day.Internal incident report was created.Bd notified.
Additional Manufacturer Narrative
Pr (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 0001391948 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.

• Brand Name: PLEURX PLEURAL CATHETER AND STARTER 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: 13904441
• Report Number: 1625685-2022-00041
• Device Sequence Number: 4065840
• Product Code: DWM
• UDI-Device Identifier: 10885403231520
• UDI-Public: (01)10885403231520
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Expiration Date: 02/28/2022
• Device Model Number: 50-7700
• Device Catalogue Number: 50-7700
• Device Lot Number: 0001391948
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/04/2022
• 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