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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG CLEANING BRUSH; TUBE, GASTRO-ENTEROSTOMY
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BARD ACCESS SYSTEMS PEG CLEANING BRUSH; TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Catalog Number 000396
Device Problems Component Falling (1105); Disconnection (1171)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/08/2016
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, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet returned for evaluation.
 
Event Description
It was reported that the tip cover was disconnected from the cleaning brush during cleaning ponsky n.B.R.Catheter.The tip cover dropped off in the body.In the opinion of the facility, the facility will wait until the tip cover is eliminated from the body.
 
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 following were reviewed as part of this investigation: patient severity, trend 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 detached flexible tip from the peg cleaning brush was confirmed, but the cause is unknown.One peg cleaning brush was returned for investigation.The returned peg cleaning brush showed that the brush was manufactured correctly.The bristles were adhered within the tip and adhesive was noted to be covering the distal end of the twisted wire where the flexible tip was attached.The cylindrical shape of the adhesive layer that covers the twisted wire indicates that the flexible tip tubing had been attached to the tip.The flexible tip tubing was not returned for investigation.The outside diameter (od) of the adhesive layer at the distal tip was measured with calipers and was found to be within specification for the inner diameter (id) of the flexible tip tubing.It was reported that the flexible tip tubing detached during use and dropped in the body.Since the tubing was not returned for investigation, the exact cause of the detachment is unknown.As it appears that the product was manufactured correctly, this is most likely a use related incident.
 
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Brand Name
PEG CLEANING BRUSH
Type of Device
TUBE, GASTRO-ENTEROSTOMY
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 Key6139558
MDR Text Key61541269
Report Number3006260740-2016-00636
Device Sequence Number1
Product Code KGC
UDI-Device Identifier0080174086816
UDI-Public(01)0080174086816
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K904779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number000396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2016
Is the Reporter a Health Professional? Yes
Event Location Home
Date Manufacturer Received12/21/2016
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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