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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 8F LOCKING PIGTAIL; PATIENT CARE SUCTION APPARATUS
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BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 8F LOCKING PIGTAIL; PATIENT CARE SUCTION APPARATUS Back to Search Results
Catalog Number NNU8LPT
Device Problem Crack (1135)
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 manufacturer has received the sample and will be evaluated.Results are expected soon.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 facility that the patient had a 8fr locking pigtail placed on (b)(6) 2017, eight days later the hub cracked.The device was removed on (b)(6) 2017, and a new device placed on (b)(6) 2017.Patient was not sure what caused the hub to crack.No patient injury reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a cracked connector on the returned drainage catheter was confirmed, but the root cause of the damage was unknown.One 8fr locking pigtail drainage catheter was returned for investigation.The product appeared to be used.The white connector was cracked into four loose fragments.Usage residue was observed on the connector fragments.The fractured surfaces of the white connector were jagged and uneven.While the damage reportedly occurred during use, the exact cause of the cracked material was not determined.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.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 facility that the patient had a 8fr locking pigtail placed on (b)(6) 2017, eight days later the hub cracked.The device was removed on (b)(6) 2017, and a new device placed on (b)(6) 2017.Patient was not sure what caused the hub to crack.No patient injury reported.
 
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Brand Name
NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 8F LOCKING PIGTAIL
Type of Device
PATIENT CARE SUCTION APPARATUS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
C.R. BARD, INC. (GFO) -1313046
289 bay road
queensbury NY 12804
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7131506
MDR Text Key95754115
Report Number3006260740-2017-02268
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801741037009
UDI-Public(01)00801741037009
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/14/2018
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 NumberNNU8LPT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 12/13/2017
Initial Date FDA Received12/19/2017
Supplement Dates Manufacturer Received01/23/2018
Supplement Dates FDA Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
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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