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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN PORT S/L; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS HICKMAN PORT S/L; IMPLANTABLE PORT Back to Search Results
Catalog Number 0603880CE
Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Medical images were provided for review.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported that some time post port device implant, the patient alleged of swelling in the arm after flushing the port.It was further reported that x-ray imaging demonstrated the catheter detached from the port body as one unit and migrated into the right ventricle.Reportedly, the catheter was removed via snare, the port body was removed in a separate procedure, and the port device was replaced.The patient status is stable post port replacement.
 
Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one mri low-profile port and one catheter lock were returned for evaluation.Visual, microscopic, functional, and dimensional evaluations were performed.The investigation is confirmed for catheter lock detachment, catheter / port disconnection, and catheter migration.The catheter was not present in the sample returned, and the catheter lock was returned loose.There was tool damage to both the catheter lock and port stem.Measurements of the id of the catheter lock and the od of the port stem were found to be within specification.Four (4) x-ray images were reviewed.The findings confirm a hickman catheter overlying the right heart, and a catheter and hub which were not connected.A definitive root cause could not be determined based on the available information.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 some time post port device implant, the patient alleged of swelling in the arm after flushing the port.It was further reported that x-ray imaging demonstrated the catheter detached from the port body as one unit and migrated into the right ventricle.Reportedly, the catheter was removed via snare, the port body was removed in a separate procedure, and the port device was replaced.The patient status is stable post port replacement.
 
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Brand Name
HICKMAN PORT S/L
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9507433
MDR Text Key174525109
Report Number3006260740-2019-03976
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741111167
UDI-Public(01)00801741111167
Combination Product (y/n)N
PMA/PMN Number
K924250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/20/2020
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 Number0603880CE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received02/20/2020
Supplement Dates FDA Received02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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