MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA PLEURAL/PERITONEAL DRAINAGE KIT 1L; PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES

Model Number	4992301
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of rebv0361 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the home health nurse has a patient with an aspira peritoneal catheter that was placed approximately one month ago.She reports that it drained properly at the hospital and she was able to drain it two days ago.The patient's abdomen is swollen, but the bulb will not inflate after it is squeezed and fluid is not draining.She states this happened with two bags.

• Brand Name: ASPIRA PLEURAL/PERITONEAL DRAINAGE KIT 1L
• Common Device Name: PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7426726
• Report Number: 3006260740-2018-00678
• Device Sequence Number: 11250153
• Product Code: FJS
• UDI-Device Identifier: 00801741045035
• UDI-Public: (01)00801741045035
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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
• Operator of Device: Health Professional
• Device Model Number: 4992301
• Device Catalogue Number: 4992301
• Device Lot Number: REBV0361
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1