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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG S/L TITANIUM LOW PROFILE PORT - JAPAN ONLY; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS GROSHONG S/L TITANIUM LOW PROFILE PORT - JAPAN ONLY; IMPLANTABLE PORT Back to Search Results
Catalog Number 0606150J
Device Problems Fracture (1260); Material Frayed (1262); Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
For the reported event, the device has not been returned for evaluation; therefore, the investigation is inconclusive for material frayed as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 0606150j.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
 
Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample was returned for evaluation, a photo was provided.Therefore, the investigation is confirmed for the fraying of the guidewire as well as the break in the inner core wire that was observed.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4.H11: g1, h2, h6 (results and conclusion).H11:section a through f - the information provided by bd 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 bd.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 0606150j.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
 
Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample was returned for evaluation, a photo was provided and is currently underway review.The company is still investigating the issue at this time.The device is labeled for single use.H11:section a through f - the information provided by bd 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 bd.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 0606150j.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
 
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Brand Name
GROSHONG S/L TITANIUM LOW PROFILE PORT - JAPAN ONLY
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9598350
MDR Text Key191156664
Report Number3006260740-2020-00160
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098253
UDI-Public(01)00801741098253
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 06/29/2020
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 No Information
Device Catalogue Number0606150J
Device Lot NumberREDS4921
Initial Date Manufacturer Received 12/31/2019
Initial Date FDA Received01/16/2020
Supplement Dates Manufacturer Received03/25/2020
06/29/2020
Supplement Dates FDA Received04/01/2020
06/29/2020
Patient Sequence Number1
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