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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG S/L TITANIUM LOW PROFILE PORT - JAPAN ONLY; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS GROSHONG S/L TITANIUM LOW PROFILE PORT - JAPAN ONLY; IMPLANTABLE PORT Back to Search Results
Catalog Number 0606150J
Device Problems Break (1069); Fracture (1260); Naturally Worn (2988)
Patient Problem Embolism (1829)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported approximately eight years post port implant the port allegedly could not aspirate.It was further reported that an alleged catheter break was identified in x-ray images and had allegedly migrated.Reportedly, the port body and distal segment of the catheter were removed.The patient was reported as stable.
 
Event Description
It was reported approximately eight years post port implant the port allegedly could not aspirate.It was further reported that an alleged catheter break was identified in x-ray images and had allegedly migrated.Reportedly, the port body and distal segment of the catheter were removed.The patient was reported as stable.
 
Manufacturer Narrative
H10: manufactuing review: a manufacturing review could not be completed as a lot number was not provided.Investigation summary: one ti low-profile port with groshong catheter in two segments and cath-lock was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for a complete catheter break due to flexural fatigue, as two catheter segments were returned with the sample.The catheter cross-section break surface at the proximal end of the distal catheter segment had a rough and granular region with sharp edges and a smooth region with rounded edges.The catheter cross-section break surface at the distal end of the proximal catheter segment also had a region with a smooth surface and round edges.Both cross-section profiles appeared to have a flattened elliptical shape.There appeared to be catheter buckling near the distal end of the proximal catheter segment.The port body and catheter segments were separately patent to infusion and aspiration with no leaks noted.The findings from the investigation are consistent with a full catheter break due to flexural fatigue.Placement, usage, physiological, material and/or mechanical factors may contribute to cyclic kinking in the catheter which may gradually form a crack/break in the catheter.Labeling review:the cause of the event in question is unknown, and so the applicability of any particular portion of the ifu or other labeling is unknown.However, 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 ifu instructs on catheter and port insertion and placement, and therefore the product labeling will be considered adequate.H10: g4; h6: device code (2889 deformation due to compressive stress, 1562 material separation, 2923 dislodged or dislocated) h11: h3, h6 (device code, 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
GROSHONG S/L TITANIUM LOW PROFILE PORT - JAPAN ONLY
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9173484
MDR Text Key161772535
Report Number3006260740-2019-02965
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098253
UDI-Public(01)00801741098253
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606150J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Date Manufacturer Received02/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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