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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PRISTINE HEMODIALYSIS CATHETER

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C.R. BARD, INC. (BASD) -3006260740 PRISTINE HEMODIALYSIS CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be 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.Device not returned.
 
Event Description
It was reported that during the procedure, catheter allegedly separated.It was further reported that the tunneler sleeve allegedly twisted.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: the physical sample was not returned for evaluation, one electronic photo was provided for review.The photo shows a clinician holding a tunneler.The sleeve of the tunneler appeared twisted.Therefore, the investigation is confirmed for the reported material twisted issue as the sleeve of the tunneler was twisted in the provided photo.However, the investigation is inconclusive for the reported detachment issue as the exact circumstances at the time of the reported event are unknown.A definitive root cause could not be determined based upon the 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.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.H3 other text: device not returned.
 
Event Description
It was reported that during catheter placement procedure, catheter allegedly detached from the tunneler during the tunneling procedure.It was further reported that the tunneler sleeve allegedly twisted.There was no reported patient injury.
 
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Brand Name
PRISTINE HEMODIALYSIS CATHETER
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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12710096
MDR Text Key278764432
Report Number3006260740-2021-04602
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/19/2021
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 NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/01/2021
Initial Date FDA Received10/28/2021
Supplement Dates Manufacturer Received11/25/2021
Supplement Dates FDA Received11/27/2021
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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