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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 8808560
Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Patient Problem Local Reaction (2035)
Event Date 11/03/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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: 10/2020).
 
Event Description
It was reported that approximately one year three months post port placement, the medication was allegedly leaked internally.It was further reported that the catheter was removed and during examination, revealed a small hole.Reportedly, the event caused a mild and controlled allergy in the patient and the catheter was replaced.The patient current status is unknown.
 
Event Description
It was reported that approximately one year three months post port placement, the medication was allegedly leaked internally.It was further reported that the catheter was removed and during examination, revealed a small hole.Reportedly, the event caused a mild and controlled allergy in the patient and the catheter was replaced.The patient current status is normal.
 
Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri isp attached to a groshong catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported fluid leak, fracture and the identified deformation due to compressive stress issue, as a circumferential split was noted approximately 3.5 cm from the distal end of the cath-lock and the edges of the circumferential split were jagged with smooth break surfaces.Upon infusion of the port body with attached catheter segment, a leak from the circumferential split was observed.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.The 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: 10/2020), g3.H11: section a through f ¿ the information provide by bd represents all 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
POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key10940567
MDR Text Key219341275
Report Number3006260740-2020-20746
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
PMA/PMN Number
K063377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2021
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 Number8808560
Device Lot NumberRECX1910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Initial Date Manufacturer Received 11/06/2020
Initial Date FDA Received12/03/2020
Supplement Dates Manufacturer Received04/03/2021
Supplement Dates FDA Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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