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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2023
Event Type  malfunction  
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 (expiry date: 05/2024).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.H3 other text : device not returned.
 
Event Description
It was reported that sometimes post dialysis catheter placement, the catheter tube allegedly broke.It was further reported that blood was coming through it.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one catheter implanted in the patient body and a fracture was noted on the red luer extension leg proximal to the hub.Therefore, the investigation is confirmed for the reported fracture issue.However, the reported fluid leak issue determined to be inconclusive.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 (expiry date: 05/2024).H11: 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 sometimes post dialysis catheter placement, the catheter tube allegedly broke.It was further reported that blood was coming through it.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
 
Event Description
It was reported that sometimes post dialysis catheter placement, the catheter tube allegedly broke.It was further reported that blood was coming through it.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one catheter implanted in the patient body and a fracture was noted on the red luer extension leg near the hub.Therefore, the investigation is confirmed for the reported fracture and fluid leak 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.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.
 
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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 Key17457309
MDR Text Key320479793
Report Number3006260740-2023-03342
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup
Report Date 02/19/2024
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 NumberREGW1907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2023
Initial Date FDA Received08/04/2023
Supplement Dates Manufacturer Received10/17/2023
02/19/2024
Supplement Dates FDA Received10/20/2023
02/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2022
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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