MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NAVARRE OPTI DRAIN; CHRONIC CATHETERS

Model Number	NOD8PT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
Event or Problem Description
It was reported that two days post dialysis catheter implant, the device allegedly had leak.Reportedly, the cathter was removed and replaced with a new catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 8f navarre drainage catheter was returned for evaluation.The inner stylet was not returned within the catheter and the device appeared to be pigtailed at the distal end of the catheter.All components were not received so functional testing was unable to be performed.Therefore, the investigation is inconclusive for the reported fluid leak issue as the exact circumstances at the time of the reported event are unknown and the issue cannot be reproduced in the lab.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: g3 h11: 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.H3 other text : see h10.
Event or Problem Description
It was reported that two days post dialysis catheter implant, the device allegedly had leak.Reportedly, the catheter was removed and replaced with new catheter.There was no reported patient injury.

• Brand Name: NAVARRE OPTI DRAIN
• 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16520346
• Report Number: 3006260740-2023-00761
• Device Sequence Number: 14032515
• Product Code: GBX
• UDI-Device Identifier: 00801741037108
• UDI-Public: (01)00801741037108
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: UNKNOWN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: NOD8PT
• Device Catalogue Number: NOD8PT
• Device Lot Number: UNKNOWN
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/25/2023
• 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