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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ascites (2596)

Event Date 07/03/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Verbatim: the patient' s daughter omit advised that the patient passed away on (b)(6) 2022.The patient' s daughter, omit, advised that the patient passed away on (b)(6) 2022.Per omit the patient had an infection and too much fluid in her stomach and couldn't breathe and the color of the fluid was red and not the brownish color they were use to seeing.Per omit, at the moment they are unaware of the exact cause of death but are waiting for some information from the doctor.

Event Description

Verbatim: the patient' s daughter omit advised that the patient passed away on (b)(6) 2022.The patient' s daughter, omit, advised that the patient passed away on (b)(6) 2022.Per omit the patient had an infection and too much fluid in her stomach and couldn't breathe and the color of the fluid was red and not the brownish color they were use to seeing.Per omit, at the moment they are unaware of the exact cause of death but are waiting for some information from the doctor.

Manufacturer Narrative

(b)(4) follow-up emdr for device evaluation: 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.

• Brand Name: PLEURX DRAINAGE KIT
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 15183430
• MDR Text Key: 297432327
• Report Number: 9680904-2022-00030
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• 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): Death