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

Catalog Number 50-9050

Device Problem Malposition of Device (2616)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).The lot number was unknown on this complaint, therefore we are unable to perform a device history record review.No complaint sample was provided for evaluation.Consequently, the investigation was not able to confirm the reported failure mode based on a complaint sample evaluation.The investigation was not able to identify any contribution from the factors noted above.Based on the complaint investigation, a probable root cause could not be identified since no complaint sample was provided for evaluation, no lot information was included in the complaint report, and no contribution was identified from the manufacturing process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

This patient of (b)(6) hospital was referred to me for a tunnelled ascitic drain that i inserted on (b)(6) 2018.She started to have severe back pain after she drained her ascitic fluid 1-2 days after the insertion.She ended up needing to have morphine for her pain.I reviewed her today and had an xray which shows the tip of the is pointing upwards at l1 level and likely behind the liver.The calcification seen on the xray is in fact calcified left liver lobe.I have spoken to her and she is keen to have it ex-planted and replaced with a new one.I am also keen to do so as she is relying heavily on morphine and i so not want her to suffer the pain from this drain insertion.My plan is to perform this procedure with aid of xray just to ensure the tip is in the pelvis.

• Brand Name: PLEURX PERITONEAL CATHETER MINI 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 7693422
• MDR Text Key: 114145513
• Report Number: 1625685-2018-00028
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 50-9050
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention