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

Model Number	0600340
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the device was allegedly broken.There was no reported patient injury.
Additional Manufacturer Narrative
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 physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported fracture issue as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available 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.(expiry date: 01/2025).
Additional Manufacturer Narrative
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 leonard 10f d/l catheter and two luer caps were returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.The investigation is confirmed for the reported catheter fracture issue as a partial circumferential break was noted on the strengthening sheath approximately 3.8cm from the bifurcation and the edges of the break appeared to be uneven and surface appeared to be granular.A definitive root cause could not be determined based upon the available 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.D4 (expiry date: 01/2025).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.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the device was allegedly broken.There was no reported patient injury.

• Brand Name: LEONARD CV CATHETER, DUAL-LUMEN,10F
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13437584
• Report Number: 3006260740-2022-00159
• Device Sequence Number: 16684722
• Product Code: LJS
• UDI-Device Identifier: 00801741051760
• UDI-Public: (01)00801741051760
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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 Model Number: 0600340
• Device Catalogue Number: 0600340
• Device Lot Number: HUEP2263
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/26/2022
• 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