MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL; CATHETER, IRRIGATION

Catalog Number	NNU6LP15
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided, therefore, the device history records were not reviewed.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that the device was allegedly cracked.Reportedly, the device was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that the device was allegedly cracked.Reportedly, the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one navarre locking pigtail 6 fr x 15cm universal drainage catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is unconfirmed for crack in device, as no cracks on the device were observed during sample evaluations.The definitive root cause could not be determined based upon available information, as the alleged device issue was unconfirmed.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.

• Brand Name: NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8200167
• Report Number: 3006260740-2018-03748
• Device Sequence Number: 13973425
• Product Code: FGE
• UDI-Device Identifier: 00801741036965
• UDI-Public: (01)00801741036965
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K955110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: NNU6LP15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1