MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE 10F, PERCUANEOS BILIARY DRAINAGE CATHETER

Model Number	NBD10
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/26/2020
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.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.A sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged string missing when package was opened issue due to the fact that no sample was returned for evaluation.The definitive root cause could not be determined.
Event or Problem Description
It was reported upon opening the drainage catheter kit, the string on the catheter was allegedly found missing.Reportedly, a new kit was opened to perform the procedure.There was no patient contact.
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 10f navarre and luer cap were returned for evaluation.Visual inspection was performed.The inner stylet was not returned with the device.A distinct pigtail curl was noted on the catheter.The wire was extending out of the distal end of the catheter.The string was not observed on the proximal hub of the device.The functional testing was not performed due to the nature of the complaint.The investigation is inconclusive for the component missing issue as the sample was returned opened and the original state of the package at the time of opening could not be confirmed, the investigation is inconclusive for the reported missing component.Although a definitive root cause could not be determined, misplacement of kit components after package opening and improper kit packaging could have potentially caused or contributed to the reported event.It is unknown whether patient and/or procedural factors contributed to the event.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.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.
Event or Problem Description
It was reported upon opening the drainage catheter kit, the string on the catheter was allegedly found missing.Reportedly, a new kit was opened to perform the procedure.There was no patient contact.
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2022), g4.H11: d4, d10, h3, h6 (method, results, conclusions).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.
Event or Problem Description
It was reported upon opening the drainage catheter kit, the string on the catheter was allegedly found missing.Reportedly, a new kit was opened to perform the procedure.There was no patient contact.

• Brand Name: NAVARRE 10F, PERCUANEOS BILIARY DRAINAGE CATHETER
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9986187
• Report Number: 3006260740-2020-01480
• Device Sequence Number: 13976333
• Product Code: FGE
• UDI-Device Identifier: 00801741036842
• UDI-Public: (01)00801741036842
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K955110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2020

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: NBD10
• Device Catalogue Number: NBD10
• Device Lot Number: GFDN0393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 07/15/2020; 09/02/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 07/30/2020; 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1