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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; IMPLANTABLE PORT Back to Search Results
Catalog Number 7707540J
Device Problems Backflow (1064); Device Appears to Trigger Rejection (1524); Obstruction of Flow (2423)
Patient Problems Occlusion (1984); Thrombus (2101)
Event Date 02/24/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.
 
Event Description
It was reported that some time post port implant, backflow of blood allegedly occurred causing occlusion.Reportedly, the device was removed and upon removal thrombus allegedly adhered to the valve at the tip of the catheter.The patient was reported as stable.
 
Event Description
It was reported that some time post port implant, backflow of blood allegedly occurred causing occlusion.Reportedly, the device was removed and upon removal thrombus allegedly adhered to the valve at the tip of the catheter.The patient was reported as stable.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the x-port isp with groshong catheter products that are cleared in the us.The pro code for the x-port isp with groshong catheter products is identified in d2.H10: manufacturing review: a lot history review, a dhr review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one x-port isp with attached groshong catheter was returned for evaluation.Gross visual, microscopic visual, dimensional and functional evaluations were performed.The investigation is inconclusive for blood back flow, occlusion and thrombus issue as the exact scenario cannot be replicated.Multiple punctures were observed on the port septum.It was observed that the cath-lock was not seated against the port body.Scoring was noted on cath-lock.A hard substance was adhered to between the port body and cath-lock.The slit in the three-way valve appeared slightly opened.Dried blood and residue were noted within the three-way valve.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.A definitive root cause could not be determined.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: g4, h6 (device, conclusion) h11: b2, d10, h3, h6 (method) 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
X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9884938
MDR Text Key185901669
Report Number3006260740-2020-01078
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098246
UDI-Public(01)00801741098246
Combination Product (y/n)N
PMA/PMN Number
K050310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7707540J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2020
Date Manufacturer Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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