MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PERITONEAL CATHETER & STARTER KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number 50-9900

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).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 Description

It was reported that expired product.Question: rep called and stated she received a call from /omit/ at (b)(6) about a physician placing an expired pleurx.The product expired on 12/31/2021 but she has no other information from the customer.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.

Manufacturer Narrative

Pr (b)(4).Follow-up emdr for device evaluation: two photos were provided to our quality team for investigation.Photos of the label were observed.The 0001367262 lot showed an expiration date of dec 31, 2021.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001367262 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.

Event 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.Lot #¿s: 50-9900 placed in patient (b)(6) 2022, lot #: 0001367262, expired 12/31/2021 further description/clarification of event: 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.

• Brand Name: PLEURX PERITONEAL CATHETER & STARTER KIT
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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: 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13772881
• MDR Text Key: 291841961
• Report Number: 1625685-2022-00040
• Device Sequence Number: 1
• Product Code: PNG
• UDI-Device Identifier: 10885403231537
• UDI-Public: (01)10885403231537
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 50-9900
• Device Catalogue Number: 50-9900
• Device Lot Number: 0001367262
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other