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

Catalog Number 50-9000B

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.

Event Description

(b)(6) did a procedure today using the pleurx peritoneal catheter and it broke inside the patient.Doctor did the case and their was no harm to the patient.The product number is 50-9000b lot number 0001305198.I believe the part that broke was the catheter insertion stylet.The catheter insertion stylet broke apart during removal.White tube end left in patient.Additional information received 29aug2019, the customer reported the patient was a male (b)(6), no injury or medical intervention, the white tubing was left in the patient's abdominal cavity, the plan is to let it remain in the patient.The facility did not report to fda.Writer called risk management and it was confirmed no part of the device would be released.

Manufacturer Narrative

Patient identifier (b)(6): only a customer provided photograph was available for analysis.The customer provided photograph was not the actual unit involved in the reported complaint event.The failure mode could not be confirmed through analysis of the customer provided photograph.A review of the device history record shows that all inspection results passed per the dhr process and no anomalies were noticed during production or during the raw material inspections.The complaint investigation was not able to confirm the reported failure mode; however, the catheter insertion stylet is a supplied drop in part.Consequently, a probable root cause could not be identified for the mannford manufacturing facility based on the investigation results.A supplier quality notification will be issued to the supplier and future occurrences will be tracked and trending will be performed as a part of our quality system.

Event Description

Ir did a procedure today using the pleurx peritoneal catheter and it broke inside the patient.Doctor did the case and their was no harm to the patient.The product number is 50-9000b lot number 0001305198.I believe the part that broke was the catheter insertion stylet.The catheter insertion stylet broke apart during removal.White tube end left in patient.Additional information received 29aug2019, the customer reported the patient was a male 68 y/o, no injury or medical intervention, the white tubing was left in the patient's abdominal cavity, the plan is to let it remain in the patient.The facility did not report to fda.Writer called risk management and it was confirmed no part of the device would be released.

• Brand Name: PLEURX PERITONEAL CATHETER 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
• MDR Report Key: 8974661
• MDR Text Key: 161416877
• Report Number: 1625685-2019-00105
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 50-9000B
• Device Lot Number: 1305198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR