MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 LEONARD CV CATHETER, DUAL-LUMEN, 10 F; CHRONIC CATHETERS

Catalog Number	0600630
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
Type of Reportable Event	Malfunction
Additional 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: 11/2026).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 or Problem Description
It was reported that one month and thirteen days post a chronic catheter placement, the white lumen allegedly broke.Reportedly, the lumen was removed and replaced.There was no reported patient injury.
Additional 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: one d/l catheter loaded to a leonard s/l catheter was received for evaluation.Visual, microscopic, tactile and functional evaluations were performed.Therefore, the investigation is unconfirmed for the reported fracture issue as no evidence of fracture was noted in 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: d4 (expiry date: 11/2026).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 or Problem Description
It was reported that one month and thirteen days post a chronic catheter placement, the white lumen allegedly broke.Reportedly, the lumen was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that one month and thirteen days post a chronic catheter placement, the white lumen allegedly broke.Reportedly, the lumen was removed and replaced.There was no reported patient injury.
Additional 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: one d/l extension set loaded to a leonard d/l catheter extension leg segment were returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A complete compound break was noted at the distal end of the leonard d/l catheter and the edges of the compound break were noted to be uneven.The distal catheter segment was not returned.Therefore the investigation is confirmed for the reported fracture and the identified material separation issues.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: d4 (expiry date: 11/2026), g3, h6 (device) h11: h6 (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.H3 other text : see h10.

• Brand Name: LEONARD CV CATHETER, DUAL-LUMEN, 10 F
• Common Device Name: 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 Key: 17376930
• Report Number: 3006260740-2023-03124
• Device Sequence Number: 12433642
• Product Code: LJS
• UDI-Device Identifier: 00801741051944
• UDI-Public: (01)00801741051944
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0600630
• Device Lot Number: HUGV0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 04/15/2024
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 12/13/2023; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown