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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 M.R.I IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0602680
Device Problems Fracture (1260); Material Separation (1562); Obstruction of Flow (2423); Malposition of Device (2616); Deformation Due to Compressive Stress (2889); Migration (4003)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2023
Event Type  malfunction  
Event Description
It was reported that sometimes post port placement procedure, the catheter allegedly went up to the internal jugular.It was further reported that the catheter allegedly ruptured.The procedure was completed using another device.The current status of the patient was unknown.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records 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.H10: d4 (expiry date: 12/2026).H11: section a through f ¿ the information provided by bd represents all 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 sometime post a port placement, the catheter allegedly did not make the path and went up to the internal jugular vein.It was further reported that the catheter was allegedly bent easily.Furthermore, the catheter was allegedly found to be obstructed.Reportedly, the catheter was replaced.There was no reported patient injury.
 
Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.H10: as the lot number for the device was provided, a review of the device history records 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.H10: d4 (expiration date: 12/2026).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.
 
Event Description
It was reported that sometime post a port placement, the catheter allegedly did not make the path and went up to the internal jugular vein.It was further reported that the catheter was allegedly bent easily.Furthermore, the catheter was allegedly found to be obstructed.Reportedly, the catheter was replaced.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one bardport implantable port kit was returned for evaluation.Visual, microscopic, functional and tactile evaluations were performed on the returned device.Upon infusion, a thrombus was observed exiting with water.Therefore the investigation is inconclusive for the reported catheter kink, obstruction and catheter malposition issue as the exact scenario of the reported events cannot be reproduced under laboratory condition.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 12/2026).H11: section a through f ¿ the information provided by bd represents all 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.
 
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Brand Name
M.R.I IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18309166
MDR Text Key330221901
Report Number3006260740-2023-05640
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741025679
UDI-Public(01)00801741025679
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K873213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/28/2024
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 Number0602680
Device Lot NumberREGZ3060
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received01/12/2024
03/28/2024
Supplement Dates FDA Received02/07/2024
04/03/2024
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
Patient Outcome(s) Required Intervention;
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