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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH; DIALYSIS CATHETER

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C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH; DIALYSIS CATHETER Back to Search Results
Catalog Number 6393190
Device Problems Fluid/Blood Leak (1250); Fracture (1260); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2023
Event Type  malfunction  
Event Description
It was reported that one month post a dialysis catheter placement, the extension part of the catheter was allegedly broken.It was further reported that the fluid was allegedly leaked from the broken part.Reportedly, the catheter was replaced.There was no reported patient injury.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2023) h11: section a through f ¿ the information provided 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.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.Two electronic photos were provided for review.The first photo shows the partial view of catheter extension leg.Air bubbles can be seen in extension leg.The reported fluid leak and fracture not observed in the photo.Second photo shows the report with device information.Product batch and expiry date and material information are correct and validated as per trackwise.Therefore, based on photo review, the identified air/gas in device can be confirmed, and also reported fluid leak and fracture are inconclusive as provided photos are not sufficient to confirm the issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2023), g3, h6 (device, method).H11: section a through f ¿ the information provided 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.
 
Event Description
It was reported that one month post a dialysis catheter placement, the extension part of the catheter was allegedly broken.It was further reported that the fluid was allegedly leaked from the broken part.Reportedly, the catheter was replaced.There was no reported patient injury.
 
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Brand Name
GLIDEPATH
Type of Device
DIALYSIS CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18001782
MDR Text Key326448171
Report Number3006260740-2023-04811
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K051748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6393190
Device Lot NumberREFV4157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/05/2023
Initial Date FDA Received10/25/2023
Supplement Dates Manufacturer Received02/02/2024
Supplement Dates FDA Received02/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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