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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/BROV 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS MRI L/P PORT W/BROV 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0603880
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Embolism (1829); Swelling (2091)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported that approximately one month post port placement the patient allegedly experienced swelling of the arm after the port was flushed.Reportedly, the catheter allegedly migrated into the left and right pulmonary artery.It was further reported that the catheter was removed with a snare and the port was removed in a separate procedure the same day.There were no further reported complications.
 
Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: g4 h11: d1, d4(lot number, udi no, product catalog no) 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
It was reported that approximately one month post port placement the patient allegedly experienced swelling of the arm after the port was flushed.Reportedly, the catheter allegedly migrated into the left and right pulmonary artery.It was further reported that the catheter was removed with a snare and the port was removed in a separate procedure the same day.There were no further reported complications.
 
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Brand Name
MRI L/P PORT W/BROV 6.6F
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9588846
MDR Text Key175092734
Report Number3006260740-2019-04129
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098949
UDI-Public(01)00801741098949
Combination Product (y/n)N
PMA/PMN Number
K072549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0603880
Device Lot NumberREDS0356
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received01/14/2020
Supplement Dates Manufacturer Received03/13/2020
Supplement Dates FDA Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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