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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 8806061
Device Problems Fracture (1260); Suction Problem (2170); Obstruction of Flow (2423)
Patient Problems Swelling (2091); Discomfort (2330)
Event Date 07/29/2020
Event Type  Injury  
Manufacturer Narrative
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, a photo has been provided for review.The investigation of the reported event is currently underway.(expiry date 03/2021).
 
Event Description
It was reported that approximately seven months post port placement in the right internal jugular vein , the catheter was allegedly unable to obtain a blood return.It was further reported that a bulge was identified on the neck while injecting saline into the port.The patient reportedly experienced discomfort.Reportedly, an x-ray was performed, the catheter was found broken, and the port was removed.The patient status was unknown.
 
Manufacturer Narrative
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 sample was not returned for evaluation,however,one electronic photo was provided for review.The investigation is inconclusive for catheter fracture and suction failure as the photo shows one catheter segment completely separated from the port but the exact circumstances at the time of the reported event are unknown.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 03/2021),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 seven months post port placement in the right internal jugular vein , the catheter was allegedly unable to obtain a blood return.It was further reported that a bulge was identified on the neck while injecting saline into the port.The patient reportedly experienced discomfort.Reportedly, an x-ray was performed, the catheter was found broken, and the port was removed.The patient status was unknown.
 
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Brand Name
POWERPORT ISP MRI 6F CHRONW/OS
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10498791
MDR Text Key205900782
Report Number3006260740-2020-03182
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098963
UDI-Public(01)00801741098963
Combination Product (y/n)N
PMA/PMN Number
K072549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/11/2020
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 Number8806061
Device Lot NumberREDS3779
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/12/2020
Initial Date FDA Received09/07/2020
Supplement Dates Manufacturer Received12/07/2020
Supplement Dates FDA Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight60
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