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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 8GR INT; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS PPRT MRI ISP 8GR INT; IMPLANTABLE PORT Back to Search Results
Model Number 9808560
Device Problems Break (1069); Fluid/Blood Leak (1250); Fracture (1260); Naturally Worn (2988)
Patient Problem Embolism (1829)
Event Date 12/18/2019
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 two years post port placement that the patient allegedly experienced subcutaneous leakage of saline, and an x-ray allegedly indicated catheter break.There was an alleged risk of catheter migration.The device was removed.The patient was reported as stable.
 
Manufacturer Narrative
H10: manufacturing review: the lot number for the device was not provided; therefore, a review of the device history records could not be performed.Investigation summary: one plastic powerport isp m.R.I.Implantable port with 8 fr s/l power groshong catheter was returned for evaluation.The sample had blood staining and fluid residue throughout and showed to be the port with a 6.7 cm length of interim power tubing inlaid under the cath-lock on the port stem and detached 14.8 cm length of distal power tubing.Initial examination of the proximal segment showed multiple access and slits of the port septum, a definitive curve in the interim tubing and the depth markings clear with a partial circumferential crack between the 15/16 cm depth markings.Initial examination of the detached tubing segment showed a definitive curve, the depth markings clear with an inclined suture crease between the 9/10 cm depth markings.The tactile evaluation showed necking of tubing at the stress, crease marks and crack sites.The complete circumferential break had smooth edges on the sides and rough edges at the top and bottom of the break.The investigation is confirmed for the break and leak, specifically caused by flexural fatigue.The definitive root cause could not be determined based upon available information.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, h6 (device code 2889) h11: h3, h6 (device), 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.
 
Event Description
It was reported approximately two years post port placement that the patient allegedly experienced subcutaneous leakage of saline, and an x-ray allegedly indicated catheter break.There was an alleged risk of catheter migration.The device was removed.The patient was reported as stable.
 
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Brand Name
PPRT MRI ISP 8GR INT
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9708832
MDR Text Key179453021
Report Number3006260740-2020-00524
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741027512
UDI-Public(01)00801741027512
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 06/15/2020
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 Model Number9808560
Device Catalogue Number9808560
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Initial Date Manufacturer Received 01/17/2020
Initial Date FDA Received02/13/2020
Supplement Dates Manufacturer Received06/15/2020
Supplement Dates FDA Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
Patient Weight59
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