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

Catalog Number 50-7245

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Pr 1727812 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

The lockable access tip disconnected from the drainage line.The patient himself temporarily glued the tube.No patient harm.On (b)(6) 2020: response received: did the access tip remain in the patient valve after the disconnection occurred? yes, the pin was locked by the bayonet lock, the valve was open by the pin getting stuck.How was it removed? loosen bayonet lock ring, pull out pin where is the catheter located? chest? abdomen? pleurx peritoneal.

Manufacturer Narrative

(b)(4) follow up emdr.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.H3 other text : na.

Event Description

The lockable access tip disconnected from the drainage line.The patient himself temporarily glued the tube.No patient harm.12aug2020: response received: did the access tip remain in the patient valve after the disconnection occurred? yes, the pin was locked by the bayonet lock, the valve was open by the pin getting stuck.How was it removed? loosen bayonet lock ring, pull out pin.Where is the catheter located? chest? abdomen? pleurx peritoneal.

• Brand Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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: 10475160
• MDR Text Key: 206153140
• Report Number: 9680904-2020-00024
• 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: distributor,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 50-7245
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 09/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other