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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 5733690
Device Problems Material Discolored (1170); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2023
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 return of the sample is pending.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).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 one month and three days post drainage catheter placement, while flushing with saline, swelling was allegedly noted.It was further reported that leakage was allegedly found in the catheter under fluoroscopy.There was no reported patient injury.
 
Event Description
It was reported that one month and three days post drainage catheter placement, while flushing with saline, swelling was allegedly noted.It was further reported that leakage was allegedly found in the catheter under fluoroscopy.The procedure was completed using another device.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: one 19cm hemosplit d/l catheter was returned for evaluation.Gross visual, tactile and functional testing were performed.In addition to the returned physical sample, one electronic image was provided for review.The investigation is confirmed for the reported fluid leak and identified discoloration issue as there is contrast extravasation in the area of the cuff noted from the provided video loop image and during visual evaluation discoloration was noted to the proximal end of the catheter.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 07/2024).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.
 
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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 Key17259835
MDR Text Key318597937
Report Number3006260740-2023-02762
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741013096
UDI-Public(01)00801741013096
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 10/09/2023
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 Model Number5733690
Device Catalogue Number5733690
Device Lot NumberREGW3145
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/09/2023
Initial Date FDA Received07/05/2023
Supplement Dates Manufacturer Received10/05/2023
Supplement Dates FDA Received10/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2022
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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