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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT CATHETER; DIALYSIS CATHETER Back to Search Results
Catalog Number 5733730
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2024) 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, a leakage was allegedly found from the extension line below the hub area.It was further reported that a little hole was allegedly found in the extension line.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
 
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 physical device was not returned for evaluation.One photo and one video was provided for review.The photo shows the implanted 23cm hemosplit catheter.The video shows blood leakage from the hole in the extension leg.Therefore, the investigation is confirmed for the reported hole in the extension leg and the fluid leak issues.A definitive root cause could not be determined based upon the provided 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: 09/2024).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, a leakage was allegedly found from the extension line below the hub area.It was further reported that a little hole was allegedly found in the extension line.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
 
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Brand Name
HEMOSPLIT 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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18388760
MDR Text Key331485646
Report Number3006260740-2023-05817
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K030020
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 02/18/2024
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 Number5733730
Device Lot NumberREHP3674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2023
Initial Date FDA Received12/22/2023
Supplement Dates Manufacturer Received02/18/2024
Supplement Dates FDA Received02/24/2024
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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