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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2 F; CHRONIC CATHETERS
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C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2 F; CHRONIC CATHETERS Back to Search Results
Catalog Number 0600060CE
Device Problems Material Fragmentation (1261); Suction Problem (2170); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2022
Event Type  malfunction  
Event Description
It was reported that some time post chronic catheter placement procedure, the catheter allegedly apprised to be damaged behind the reinforced part.It was further reported that the catheter allegedly had suction issue.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the broviac 4.2 f single-lumen cv catheter that are cleared in the us.The pro code and 510 k number for the broviac 4.2 f single-lumen cv catheter are identified.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 were provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2025).
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the broviac 4.2 f single-lumen cv catheter that are cleared in the us.The pro code and 510 k number for the broviac 4.2 f single-lumen cv catheter are identified in d2 and g4.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 sample was not returned for evaluation, one electronic photo was provided for review.The photo shows a physician holding one hickman s/l cvc catheter.Peeling was observed on the mid of the catheter.Fragments of catheter was noted to be missed from the surface of the catheter.However, the exact cause of the missing fragments of catheter surface was known.Therefore, the investigation is inconclusive for the reported material fragmentation and suction issues as the exact circumstances at the time of reported event was unknown and cannot be confirmed from the provided photo.A definitive root cause for the over stretch and/or over pressure 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: d4 (expiry date: 05/2025), g3, h6(method) h11: h6(device, result, conclusion) 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.Device not returned.
 
Event Description
It was reported that some time post chronic catheter placement procedure, the catheter allegedly apprised to be damaged behind the reinforced part.It was further reported that the catheter allegedly had suction issue.There was no reported patient injury.
 
Event Description
It was reported that some time post chronic catheter placement procedure, the catheter allegedly apprised to be damaged behind the reinforced part.It was further reported that the catheter allegedly had suction issue.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the broviac 4.2 f single-lumen cv catheter that are cleared in the us.The pro code and 510 k number for the broviac 4.2 f single-lumen cv catheter are identified in d2 and g4.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 sample was not returned for evaluation.Two electronic photos were provided for review.The investigation is confirmed for the reported material fragmentation issue as peeling was observed on the mid of the catheter.Furthermore, fragments of catheter was noted to be missed from the surface of the catheter.But, the exact cause of the missing fragments of catheter surface was known.However, the investigation is inconclusive for the reported suction issues as the exact circumstances at the time of reported event was unknown and cannot be confirmed from the provided photo.A definitive root cause for the over stretch and/or over pressure 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.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.
 
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Brand Name
BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2 F
Type of Device
CHRONIC CATHETERS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key14925823
MDR Text Key302345624
Report Number3006260740-2022-02518
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K830233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 01/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0600060CE
Device Lot NumberHUET0572
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2020
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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