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	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, at this time, for evaluation.A lot history review (lhr) of recn1066 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the patient that the drainage on her aspira bag has decreased.There was no reported patient injury.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device returned was one 1-l aspira plueral/peritoneal drainage kit, unopened.Visual observation found that the bag was not opened.The device appeared in good condition.Microscopic evaluation of the valve stem of the adaptor was unremarkable.Tactual evaluation of the device was also unremarkable.Functional testing of the bulb by compressing it repeatedly found that air was drawn into the bag.The adaptor was placed in a water source with the bag extending down below.The siphon pump was engaged one time, which induced continuous flow into the bag until the fluid line extended over the 1000 ml marker on the bag.Orienting the device differently contributed to variation in flow rate, but at no time did flow cease.The complaint of slow drainage from an aspira drainage bag cannot be confirmed since the sample returned was not the original bag.Potential causes of the reported event include increased thickness of fluid, damaged valve, loculated fluid, catheter or drainage system kinking, improper connection, incomplete seal, orientation of the drainage bag, and dislodged catheter.A lot history review (lhr) of recn1066 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the patient that the drainage on her aspira bag has decreased.There was no reported patient injury.

• 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: 7438562
• Report Number: 3006260740-2018-00725
• Device Sequence Number: 16657338
• Product Code: FJS
• UDI-Device Identifier: 00801741045035
• UDI-Public: (01)00801741045035
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: Lay User/Patient
• Device Model Number: 4992301
• Device Catalogue Number: 4992301
• Device Lot Number: RECN1066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1