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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS ASPIRA PERITONEAL DRAINAGE; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING Back to Search Results
Catalog Number UNKNOWN
Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Patient Problems Discomfort (2330); Abdominal Distention (2601)
Event Date 09/24/2017
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.Sample remains in patient.
 
Event Description
It was reported that the home care nurse was attempting to drain an aspira peritoneal patient on (b)(6) 2017.The nurse stated this was the first attempt at drainage since catheter placement on (b)(6) 2017.The nurse stated she had tried two drainage kits and noted very little drainage, even though the patient was distended and uncomfortable.She also noted there was leakage coming from the insertion and exit sites of the catheter.
 
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Brand Name
ASPIRA PERITONEAL DRAINAGE
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
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key6949746
MDR Text Key89969514
Report Number3006260740-2017-01837
Device Sequence Number1
Product Code PNG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/13/2017
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
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/13/2017
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 Number1
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