MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number 50-7510

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported: one leaked at the connection all over.Had to replace with new bottle.Is the product that leaked, separate from the bottles with the tip issue? where did the leak occur? where is the catheter located? when was the catheter placed? on (b)(6) 2020, i spoke with patient via telephone.One bottle leaked, the leak occurred between the access tip and the drainage line.The access tip properly clicked into place when connected.There was no damage, or other defects observed on the access tip, or the patient valve that would have contributed to the leak.Immediately stopped the drain and used a new bottle to complete.No additional issues with leaks have occurred since.Catheter was placed in (b)(6) 2020, and is located on her abdomen.

Manufacturer Narrative

(b)(6) 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 0001361150 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 quality team's investigation, we cannot identify a root cause related to our manufacturing process at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends h3 other text : see manufacturer narrative.

Event Description

It was reported: one leaked at the connection all over.Had to replace with new bottle.Is the product that leaked, separate from the bottles with the tip issue? where did the leak occur? where is the catheter located? when was the catheter placed? (b)(6) 2020: spoke with patient via telephone.One bottle leaked, the leak occurred between the access tip and the drainage line.The access tip properly clicked into place when connected.There was no damage or other defects observed on the access tip or the patient valve that would have contributed to the leak.Immediately stopped the drain and used a new bottle to complete.No additional issues with leaks have occurred since.Catheter was placed in (b)(6) 2020 and is located on r abdomen.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 10678847
• MDR Text Key: 211327446
• Report Number: 9680904-2020-00029
• 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: consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 50-7510
• Device Lot Number: 0001361150
• Date Manufacturer Received: 09/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other