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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
Model Number 5743690
Device Problems Fracture (1260); Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/19/2023
Event Type  malfunction  
Event Description
It was reported that prior to a dialysis catheter placement procedure, the white rubber tube of the tunneller inside the dialysis catheter was allegedly found to be ruptured.The procedure was completed using another device.There was no patient contact.
 
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 (expiration 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 prior to a dialysis catheter placement procedure, the white rubber tube of the tunneller inside the dialysis catheter was allegedly found to be ruptured.The procedure was completed using another device.There was no patient contact.
 
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 physical device was not returned for evaluation.One electronic photo was provided for review.The photo shows the tunneler along with the white rubber tube.The tube part has been broken.Based on the photo review, the reported fracture can be confirmed.Therefore, the reported device damaged prior to use has been kept inconclusive as the exact time of the event occurred is unknown.A definitive root cause for the reported event 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: 05/2024), g3, h6 (device, method).H11: h6 (result, conclusion).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.
 
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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 Key17334999
MDR Text Key319342869
Report Number3006260740-2023-03010
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741013263
UDI-Public(01)00801741013263
Combination Product (y/n)N
Reporter Country CodeCH
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 10/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5743690
Device Catalogue Number5743690
Device Lot NumberREGX3524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2023
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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