MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA; SUCTION APPARATUS

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

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

Per (b)(6), the patient's daughter reported that her mother had fluid leaking around the insertion site of the aspira.She states that she changed the dressing around the insertion site more than three times a day with the dressing being saturated with fluid each time.The daughter said she performs daily drainage with approximately 1200ccs with each drainage.She asked (b)(6) if there is anything to stop the leaking.(b)(6) stated that the leakage can occur from excessive pressure in the abdomen leading to backpressure build up and leakage.They explained that leakage around the insertion site can be caused when the peritoneal catheter is tunneled downward rather than superior and medial to the insertion site.The patient's daughter stated that the catheter looked horizontal.(b)(6) explained that a clogged drainage catheter can cause leakage, also when the catheter is displaced and the fenestrations are not inside the peritoneal space.(b)(6) suggested to report to the patient's doctor for follow up.

• Brand Name: ASPIRA
• Type of Device: SUCTION APPARATUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• 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: 6297928
• MDR Text Key: 66683319
• Report Number: 3006260740-2017-00037
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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?: No
• Event Location: Hospital
• 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