MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 UNKNOWN ASPIRA PERITONEAL; PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES

Catalog Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Discharge (2225)

Event Type  malfunction  

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.

Event Description

Hospice nurse reported when she came to see the patient on (b)(6) she drained 500ml using a pleurx bottle.She stated that now she thinks the valve is broken.(b)(6) advised accessing the catheter with unapproved supplies can damage the valve.(b)(6) had her occlude catheter with slide clamp and provided product codes for the replacement valve.The nurse will contact the physician.No patient injury reported.

• Brand Name: UNKNOWN ASPIRA PERITONEAL
• Type of Device: PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6503513
• MDR Text Key: 73380448
• Report Number: 3006260740-2017-00438
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• 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