MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 2.7F BROVIAC CV CATHETERS 0.5 MM LUMEN REPAIR KIT; PORT AND CATHETER ACCESSORIES

Model Number	0601600
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Fracture (1260); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one month post catheter placement procedure, the device was allegedly noted to be broken and leaking.It was further reported that the cuff of the device exposed.The device was repaired.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 08/2022).Device not returned.
Event or Problem Description
It was reported that four months post catheter placement procedure, the device was allegedly noted to be broken and leaking.It was further reported that the cuff of the device exposed.The device was repaired.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.There was nothing found to indicate there was a manufacturing related cause for this event.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 and leak issues, 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.H10: d4 (expiry date: 08/2022).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.
Event or Problem Description
It was reported that four months post catheter placement procedure, the device was allegedly noted to be broken and leaking.The device was repaired.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.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one broviac s/l repair catheter was returned for evaluation.Gross visual, microscopic visual, tactile and functional evaluations were performed on the returned device.The investigation is confirmed for the reported fracture, fluid leak identified burst issues as a c-shaped compound break was noted on the catheter approximately 0.6cm distal to the clamping sleeve.The surface was smooth and granular and the edges were uneven.Further during functional evaluation, a leak from the compound break was noted upon infusing the 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.H10: d4 (expiry date: 08/2022).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: 2.7F BROVIAC CV CATHETERS 0.5 MM LUMEN REPAIR KIT
• Common Device Name: PORT AND CATHETER ACCESSORIES
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12777468
• Report Number: 3006260740-2021-04718
• Device Sequence Number: 17579777
• Product Code: LJS
• UDI-Device Identifier: 00801741036378
• UDI-Public: (01)00801741036378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2022

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: 0601600
• Device Catalogue Number: 0601600
• Device Lot Number: REFP0281
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 01/26/2022; 04/04/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/28/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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