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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TI POWERPORT LOW PROFILE - JAPAN ONLY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS TI POWERPORT LOW PROFILE - JAPAN ONLY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 1716000J
Device Problem Fluid/Blood Leak (1250)
Patient Problem Unspecified Infection (1930)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
Photos were provided to the manufacturer.The lot number was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.
 
Event Description
It was reported approximately five days post continuous administration of total parenteral nutrition (tpa) via port placed in the right internal jugular vein, allegedly a subcutaneous leak was identified around the port pocket.Reportedly, the port system was removed.It was further reported that suppuration was identified and infection was confirmed.There were no further complications reported.
 
Event Description
It was reported approximately five days post continuous administration of total parenteral nutrition (tpa) via port placed in the right internal jugular vein, allegedly a subcutaneous leak was identified around the port pocket.Reportedly, the port system was removed.It was further reported that suppuration was identified and infection was confirmed.There were no further complications reported.
 
Manufacturer Narrative
H10: manufacturing review: a lot history record review could not be completed as the lot number was not provided.Investigation summary: one electronic photo was reviewed.The photo shows a titanium powerport with attached chronoflex catheter and cathlock.The cathlock is seated over the port stem and catheter with the radiopaque ring oriented distally, and the cathlock appears to be seated against the port body.There appears to be some markings on the port septum.The port septum itself does not appear to be appreciably deformed, and no other anomalies are apparent in the photo.Based on the photo review, the reported leak could not be confirmed.One ti powerport low-profile port with attached catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.A photo was provided and reviewed.The investigation is unconfirmed for leaking from the port and leaking from the port/catheter connection, as the sample was freely patent to infusion and aspiration, and no leaks were observed even under much increased hydraulic pressure during sample evaluation.A slit was observed on the port septum, and the slit appeared to be mostly straight.The distal end of the catheter had sharp edges, and the cross-sectional surfaces appeared to be smooth with striations.The definitive root cause could not be determined based upon available information, as the reported event could not be reproduced during sample evaluation.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: g4 h11: h3, h6(results, 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.
 
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Brand Name
TI POWERPORT LOW PROFILE - JAPAN ONLY
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 Key9521975
MDR Text Key174526845
Report Number3006260740-2019-04017
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741111631
UDI-Public(01)00801741111631
Combination Product (y/n)N
PMA/PMN Number
K050310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/09/2020
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 Number1716000J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received06/08/2020
Supplement Dates FDA Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age90 YR
Patient Weight50
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