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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; IMPLANTED PORTS
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BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; IMPLANTED PORTS Back to Search Results
Catalog Number 0603880C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombus (2101)
Event Date 02/21/2020
Event Type  Injury  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified.As the lot number for the device was provided, a manufacturing review will 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.Device expiry date (08/2021).
 
Event Description
It was reported that approximately three months post port placement in the right chest wall through the right internal jugular vein, the patient allegedly developed thrombosis that was identified under ultrasound.It was further reported that the port was successfully removed under local anesthesia after thrombolytic therapy.The patient was reportedly discharged the same day.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified in d2 and g5.H10: manufacturing review:the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the device was not returned for evaluation.Therefore, the reported thrombosis cannot be confirmed.A definitive root cause could not be determined based upon available information.Labeling review:a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2021),g4.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 three months post port placement in the right chest wall through the right internal jugular vein, the patient allegedly developed thrombosis that was identified under ultrasound.It was further reported that the port was successfully removed under local anesthesia after thrombolytic therapy.The patient was reportedly discharged the same day.
 
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Brand Name
M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
Type of Device
IMPLANTED PORTS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10312615
MDR Text Key200023192
Report Number3006260740-2020-02600
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 01/22/2021
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 Number0603880C
Device Lot NumberRECV2773
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/01/2020
Initial Date FDA Received07/23/2020
Supplement Dates Manufacturer Received01/21/2021
Supplement Dates FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
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