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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 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 8806061
Device Problems Fluid/Blood Leak (1250); Difficult to Flush (1251); Failure to Infuse (2340); Material Protrusion/Extrusion (2979)
Patient Problem Extravasation (1842)
Event Date 09/28/2021
Event Type  Injury  
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.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2021).Device not returned.
 
Event Description
It was reported that post port device implant, the catheter of the device allegedly protruded.It was further reported that medication flow was interrupted and extravasation of chemotherapy drugs were noted.The device was surgically removed and replaced.The current status of the patient is unknown.
 
Event Description
It was reported that post port device implant, the catheter of the device allegedly protruded.It was further reported that medication flow was interrupted and extravasation of chemotherapy drugs were noted.Reportedly, device was surgically removed and replaced.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: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport isp implantable port was returned for evaluation and one electronic photo was provided for review.The investigation is confirmed for the reported material protrusion issue as the port septum appeared to be partially dislodged from the port body, the photo review also confirms the same.However, the investigation is inconclusive for the reported flushing and leak issues as the exact circumstances at the time of the reported event are unknown and the cannot be evaluated during sample evaluation due to the condition of the returned device.The 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: 11/2021).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 : see h10.
 
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: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The investigation is inconclusive for the reported difficult to flush and fluid leak issue as the exact circumstances at the time of reported event was unknown and cannot be confirmed from the provided photo review.However, the investigation is confirmed for the reported septum dislodgement as the lumen of the septum was protruding the powerport in the provided photo.The 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: 11/2021), g3, h6 (method).H11: d6 (medical device implant date), h6 (device, result, conclusion).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 post port device implant, the catheter of the device allegedly protruded.It was further reported that medication flow was interrupted and extravasation of chemotherapy drugs were noted.The device was surgically removed and replaced.The current status of the patient is unknown.
 
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Brand Name
POWERPORT ISP MRI 6F CHRONW/OS
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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12687169
MDR Text Key278086079
Report Number3006260740-2021-04518
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098963
UDI-Public(01)00801741098963
Combination Product (y/n)N
Reporter Country CodeBR
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 Physician
Type of Report Initial,Followup,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8806061
Device Lot NumberREDZ0880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
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) Other;
Patient Age37 YR
Patient SexFemale
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