MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 2.7F; CHRONIC CATHETERS

Catalog Number	0600040
Medical Device Problem Codes	Partial Blockage (1065); Material Discolored (1170); Restricted Flow rate (1248); Deformation Due to Compressive Stress (2889); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
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.However, a photo was provided for review.The investigation of the reported event is currently underway.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 ten months and nineteen days post a chronic catheter placement via the right external jugular vein, the white plastic part of the connection and the transition area of the catheter had allegedly turned black, which allegedly caused the narrowing of the catheter.There was no reported patient injury.
Event or Problem Description
It was reported that ten months and nineteen days post a chronic catheter placement via the right external jugular vein, the white plastic part of the connection and the transition area of the catheter had allegedly turned black, which allegedly caused the narrowing of the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one broviac s/l catheter was returned for evaluation.Along with the sample, one photo was provided for review.Functional, gross visual, tactile and microscopic visual evaluations were performed.The complaint sample had residue and discoloration throughout.Small yellow stains were noted on both sides of the catheter hub and under microscopic observation, yellow residue was noted within the catheter hub.Therefore, the investigation is confirmed for the reported material discoloration as discoloration was noted throughout the catheter, partial blockage and identified contamination issues.However, the investigation is inconclusive for reported restricted flow issues as no objective evidence for reported flow issue was obtained during evaluation of the returned catheter.The definitive root cause could not be determined based upon 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.Label reviewed: baw0713603 the instruction for use states: site care 8.Carefully clean the catheter exit site with an alcohol swabstick or sterile cotton tipped applicator, soaked in hydrogen peroxide, starting at the exit site and spiraling outward until a circle at least 8 cm in diameter, has been cleaned.Do not return to the catheter exit site with a swabstick that has touched any skin away from the exit site.11.Gently clean the outside of the catheter with the inside surface of an alcohol wipe, starting from the exit site to the catheter connector.You may hold the catheter at the exit site with another alcohol wipe to prevent pulling on the catheter.H10: g3, h6 (device).H11: d4(unique identifier (udi) #), h6 (method, result, conclusion).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.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 2.7F
• 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 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 Key: 20766327
• Report Number: 3006260740-2024-06939
• Device Sequence Number: 12860302
• Product Code: LJS
• UDI-Device Identifier: 00801741036309
• UDI-Public: (01)00801741036309(11)230630(17)260430(10)REHS2334
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/03/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 0600040
• Device Lot Number: REHS2334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 11/23/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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 Age: 11 MO
• Patient Sex: Unknown