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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 5396240
Device Problems Fracture (1260); Difficult to Insert (1316); Stretched (1601); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2023
Event Type  malfunction  
Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.H3 other text : device pending return.
 
Event Description
It was reported that during a dialysis catheter placement procedure, there was strong resistance felt during inserting the guidewire, after puncturing the needle.It was further reported that the device allegedly broken upon removal.Reportedly, another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one j-tip guidewire, one introducer needle, one guidewire hoop and one needle protector were received for evaluation.Visual and functional evaluations were performed.The proximal portion of the j-tip guidewire was noted to be uncoiled and stretched.The distal portion of the j-tip guidewire was noted to be bent.Therefore, the investigation is confirmed for the identified deformation due to compressive stress and stretched issues.However, the investigation is inconclusive for the reported physical resistance and difficult to insert issues as the exact circumstance at the time of the event reported was unknown.The investigation is also unconfirmed for the reported fracture issue as no fracture was noted.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 : see h10.
 
Event Description
It was reported that during a dialysis catheter placement procedure, there was strong resistance felt during inserting the guidewire, after puncturing the needle.It was further reported that the device was allegedly broken upon removal.Reportedly, another device was used to complete the procedure.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 Key17761954
MDR Text Key323580800
Report Number3006260740-2023-04133
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741012259
UDI-Public(01)00801741012259
Combination Product (y/n)N
Reporter Country CodeJA
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 11/24/2023
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 Number5396240
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/21/2023
Initial Date FDA Received09/16/2023
Supplement Dates Manufacturer Received11/21/2023
Supplement Dates FDA Received11/27/2023
Was Device Evaluated by Manufacturer? Yes
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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