MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. ASPIRA VALVE REPAIR KIT

Model Number N/A

Device Problems No Device Output (1435); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Nurse states she has a patient with an aspira pleural catheter.The patient went out for rehab and while there the staff accessed his catheter with pleurx supplies.Now she is reportedly unable to get drainage from the catheter.Note: she added later there are two catheters (bilateral) and neither are draining.She confirms both were accessed with pleurx supplies.Advised the pleurx supplies could have damaged the aspira valve.She will call the physician and discuss replacing the valve.

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) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: ASPIRA VALVE REPAIR KIT
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; reynosa, tamaulipas ; MX
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4798480
• MDR Text Key: 5925546
• Report Number: 3006260740-2015-00230
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: OPTIONAL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4992306
• Device Lot Number: REQUESTED BUT NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention