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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (BASD) -3006260740 HEMOSTAR; DIALYSIS CATHETER Back to Search Results
Catalog Number 5833690
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2023
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 video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2024).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.
 
Event Description
It was reported that sometime post a dialysis catheter placement in the right internal jugular vein, a break was allegedly found at the outlet.It was further reported that the catheter allegedly leaked.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 video was provided for review.The video shows partial view of dialysis hemostar catheter implanted in the patient, both the extension legs was filled with blood.Physician holding left side of extension leg while moving the extension leg fracture was noted and blood was leaking from the fracture.Physician removing the leak blood through cotton swab.Therefore, the investigation is confirmed for the reported fracture and leak issues.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.H10: (expiration date: 11/2024).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 sometime post a dialysis catheter placement in the right internal jugular vein, a break was allegedly found at the outlet.It was further reported that the catheter allegedly leaked.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
 
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Brand Name
HEMOSTAR
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 Key18411641
MDR Text Key331549564
Report Number3006260740-2023-05906
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeCH
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 02/25/2024
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 Number5833690
Device Lot NumberREHN2472
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2023
Initial Date FDA Received12/28/2023
Supplement Dates Manufacturer Received02/25/2024
Supplement Dates FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2023
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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