MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN CHRONIC CATHETER; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number UNKNOWN

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problems Discomfort (2330); Abdominal Distention (2601)

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

It was reported by the nurse that she has a patient with a peritoneal aspira for ascites drainage.The catheter was draining 700-1000 daily when aspira bottles were used.Nurse stated bottles were used because she had run out of drainage bags.The nurse was unsure if she used aspira or pleurx bottles to drain.When she returned to using drainage bags the nurse noticed a dramatic decrease in the amount of fluid that drained; patient was distended and uncomfortable.Medical services advised the nurse to aspirate fluid with a luer slip syringe.It was reported that the nurse used a foley syringe and met resistance.Patient was taken to the hospital for drainage and noted that the valve was damaged and had to be repaired.

• Brand Name: UNKNOWN CHRONIC CATHETER
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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: 7268353
• MDR Text Key: 100232909
• Report Number: 3006260740-2018-00195
• 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
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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: 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