MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NAVARRE UNIVERSAL DRAIN; DRAINAGE CATHETER

Catalog Number NNU10LPT

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being 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: 02/2024).

Event Description

It was reported that during a procedure, the stiffener was allegedly left in the patient body.Surgical intervention needed to remove the device.Patient status was reported as stable.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure 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.Instruction for use reviewed and it indicates: 1.Use diagnostic imaging to direct the catheter into fluid collection site.(use the seldinger or trocar technique).2.Remove the cannula and guidewire or the trocar stylet.3.Lock the catheter loop.H10: d4 (expiry date: 02/2024), g3.H11: h6 (device, method).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 Description

It was reported that during a procedure, the stiffener was allegedly left in the patient body.Surgical intervention needed to remove the device.Patient status was reported as stable.

• Brand Name: NAVARRE UNIVERSAL DRAIN
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12279079
• MDR Text Key: 265135890
• Report Number: 3006260740-2021-03160
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: K951475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NNU10LPT
• Device Lot Number: GFFP0457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention