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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EQUISTREAM SPLIT TIP; DIALYSIS CATHETER
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C.R. BARD, INC. (BASD) -3006260740 EQUISTREAM SPLIT TIP; DIALYSIS CATHETER Back to Search Results
Catalog Number 6903230
Device Problems Obstruction of Flow (2423); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2023
Event Type  malfunction  
Event Description
It was reported that sometimes post a dialysis catheter placement, the blood flow was allegedly not smooth.It was further reported that while aspirating the blood, air bubble was allegedly observed in the syringe.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
 
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.The investigation of the reported event is currently underway.H10: d4 (expiry 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 pending return.
 
Event Description
It was reported that sometimes post a dialysis catheter placement, the blood flow was allegedly not smooth.It was further reported that while aspirating the blood, air bubble was allegedly observed in the syringe.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: one 23cm equistream d/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in-house syringe was attached to the luers and was patent to infusion and aspiration.No bubbles were observed throughout the in-house syringe.Therefore the investigation is inconclusive for the reported obstruction and air in the device issues as there were no bubbles and obstruction was identified during evaluation and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm that this event did not occur under clinical conditions.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 (expiry date: 05/2024), g3.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
EQUISTREAM SPLIT TIP
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 Key18472872
MDR Text Key333092376
Report Number3006260740-2023-06087
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741121654
UDI-Public(01)00801741121654
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K090101
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 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6903230
Device Lot NumberREGT4633
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2022
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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