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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG PORT S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS GROSHONG PORT S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0603870C
Device Problems Break (1069); Emergency Power Failure (1205); Fluid/Blood Leak (1250); Suction Problem (2170)
Patient Problem Injury (2348)
Event Date 11/25/2019
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.(expiry date 03/2022).
 
Event Description
It was reported that one month post port placement procedure in the left subclavian vein, the port allegedly failed to aspirate.It was further reported that subcutaneous extravasation was allegedly identified and it was suspected that the catheter was damaged.Reportedly, the port was removed and damage was allegedly identified near the port hub.Another procedure was performed to remove the port body and catheter, and a new port was placed.The patient was reportedly stable post procedure.
 
Event Description
It was reported that one month post port placement procedure in the left subclavian vein, the port allegedly failed to aspirate.It was further reported that subcutaneous extravasation was allegedly identified and it was suspected that the catheter was damaged.Reportedly, the port was removed and damage was allegedly identified near the port hub.Another procedure was performed to remove the port body and catheter, and a new port was placed.The patient was reportedly stable post procedure.
 
Manufacturer Narrative
H10:manufacturing review: manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.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.Investigation summary: one mri low-profile with attached groshong catheter was received for evaluation.Gross examination of the port segment showed multiple puncture access of the port septum.A circumferential split was noted at approximately 1.9cm from the distal end of the port body.Catheter tubing with generally clear and distinct depth markings and a perceived curve, a partial circumferential inclined 2.8 mm length slit between the 27/28 cm depth markings approximately 1.1 cm distal to the port stem.The tactile evaluation showed necking at the split site.The sample was patent to infusion and leaking was observed at the proximal holes and crack/split sites.The investigation confirms the catheter damaged and extravasation issue.A definitive root cause could not be determined.H10: g4, h6 (device code -1260 fracture) h11: d10, h3, h6 (method, 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 PORT S/L
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 Key9517024
MDR Text Key174526766
Report Number3006260740-2019-04008
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741111280
UDI-Public(01)00801741111280
Combination Product (y/n)N
PMA/PMN Number
K081311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/23/2020
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 Number0603870C
Device Lot NumberREDR3694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2020
Initial Date Manufacturer Received 12/03/2019
Initial Date FDA Received12/24/2019
Supplement Dates Manufacturer Received06/23/2020
Supplement Dates FDA Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient Weight60
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