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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 8CF INT. W/SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 8CF INT. W/SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 8808060
Device Problem Material Twisted/Bent (2981)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/16/2022
Event Type  Injury  
Event Description
It was reported that approximately one month post port placement procedure, the catheter allegedly twisted near the jugular vein.Reportedly the port was repositioned.Reportedly patient experienced jugular thrombosis which required anti-coagulation for treatment.The current status of the patient is unknown.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the powerport implantable port products that are cleared in the us.The pro code and 510k number for the powerport implantable port products is identified in common device name and 510k.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2023).
 
Event Description
It was reported that approximately one month post port placement procedure, the catheter allegedly twisted near the jugular vein.Reportedly the port was repositioned.Reportedly patient experienced jugular thrombosis which required anti-coagulation for treatment.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport implantable port products that are cleared in the us.The pro code and 510k number for the powerport implantable port products is identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the sample was not returned for evaluation, one image was provided for review.The image shows a catheter within the internal jugular vein.The investigation is inconclusive for the reported material twisted/bent issue, as from the specific view it is not possible to determine the specific orientation of the catheter.A definitive root cause could not be determined based upon the 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: 02/2023).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.H3 other text : device not returned.
 
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Brand Name
POWERPORT ISP MRI 8CF INT. W/SP, ATT, SL
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 Key15638399
MDR Text Key306832723
Report Number3006260740-2022-04103
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098970
UDI-Public(01)00801741098970
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K063377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8808060
Device Lot NumberREFU1548
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2021
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;
Patient Age55 YR
Patient SexMale
Patient Weight79 KG
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