• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F Back to Search Results
Model Number 5703690
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2023
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, photos and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2024) 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.
 
Event Description
It was reported that approximately less than two months post dialysis catheter placement, blood exudation allegedly occurred from the catheter body during routine dialysis.It was further reported that the catheter body had allegedly cracked.The procedure was completed using another device.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 sample was not returned for evaluation.Two electronic photos and one video were reviewed.Both photographs showed a patient with a clinician holding a swab at or near the catheter, near the catheter exit site.There was a small amount of blood in the area immediately surrounding the exit site.In the video the clinician is still holding the swab, and repeatedly touches it to the catheter just below the exit site while pushing the catheter inward (into the patient) somewhat, so that it bends slightly.No source of bleeding or leak was apparent.No damage to the catheter was apparent.Therefore, based on the photo and video review, the reported catheter crack and leakage cannot be confirmed.A definitive root cause for the reported cracking and blood exudation could not be determined based upon the provided 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.H10: (expiry date: 02/2024).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 approximately less than two months post dialysis catheter placement, blood exudation allegedly occurred from the catheter body during routine dialysis.It was further reported that the catheter body had allegedly cracked.The procedure was completed using another device.There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F
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 Key17369514
MDR Text Key319677676
Report Number3006260740-2023-03099
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741012884
UDI-Public(01)00801741012884
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 09/15/2023
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 Number5703690
Device Catalogue Number5703690
Device Lot NumberREGQ2661
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/29/2023
Initial Date FDA Received07/21/2023
Supplement Dates Manufacturer Received09/15/2023
Supplement Dates FDA Received09/17/2023
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
-
-