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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reaz1045 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported to ms&s, that the aspira catheter is not draining.Fluid is present in the tubing, but will not drain into the bag.Ms&s advised the complainant that the valve may be damaged and need to be replaced.No patient injury was reported.

• 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: 6715675
• Report Number: 3006260740-2017-01053
• Device Sequence Number: 1538718
• Product Code: FJS
• UDI-Device Identifier: 10801741091145
• UDI-Public: (01)10801741091145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

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: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4992209
• Device Lot Number: REAZ1045
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1