MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA VALVE REPAIR KIT; PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES

Model Number	4992306
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by (b)(6) that the nurse called and stated she had a patient who has two aspira pleural drainage tubes in and one of the valves "fell off".She stated the patient was able to find the valve and replace it.The tubes were placed in (b)(6) 2017.The patient told the nurse, "it just fell off and i didn't realize until i felt something wet.I was able to find it and put it back on.".
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 complaint that the valve fell off the aspira drainage catheter was inconclusive based on the evidence that was provided for investigation.Four photographs were provided, which showed what appeared to be two separate aspira drainage catheters.The valves were attached to each tube.The condition of the drainage tube, whether the tube was fully inserted on the valve, and stresses acting on the device at the time of detachment were unknown, but are potential contributing factors.In the case of valve or catheter damage, the aspira valve assembly / repair kit may be used to replace the valve.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by ms&s that the nurse called and stated she had a patient who has two aspira pleural drainage tubes in and one of the valves "fell off".She stated the patient was able to find the valve and replace it.The tubes were placed in (b)(6) and (b)(6) 2017.The patient told the nurse, "it just fell off and i didn't realize until i felt something wet.I was able to find it and put it back on.".

• Brand Name: ASPIRA VALVE REPAIR KIT
• 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: 6861776
• Report Number: 3006260740-2017-01582
• Device Sequence Number: 873471
• Product Code: FJS
• UDI-Device Identifier: 00801741045059
• UDI-Public: (01)00801741045059
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K110396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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 Model Number: 4992306
• Device Catalogue Number: 4992306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Event Location: Home
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1