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

Model Number NNU8LPT

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895); Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007); Device Fell (4014); Device Contaminated at the User Facility (4064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).

Event Description

It was reported that prior to an ultrasound-guided catheter placement, the device allegedly fell off on floor and contaminated due to packaging problem.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

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 sample was not returned for evaluation, three electronic photos were provided for review.However, the provided photos are not sufficient enough to confirm the reported issues.Therefore, the investigation is inconclusive for the reported contamination, device fell and difficult to open or remove issues as the exact circumstances at the time of the reported event are unknown.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.D4 (expiry date: 02/2024).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 Description

It was reported that prior to an ultrasound-guided catheter placement, the device allegedly fell off on floor and contaminated due packaging problem.The procedure was completed using another device.There was no patient contact.

Event Description

It was reported that prior to an ultrasound-guided catheter placement, the device allegedly fell off on floor and contaminated due packaging problem.The procedure was completed using another device.There was no patient contact.

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 sample was not returned for evaluation.Three electronic photos were provided for review.However, the provided photos are not sufficient to confirm the reported issues with opening the packaging of the device and the device falling and being contaminated.Therefore, the investigation is inconclusive for the reported failures as the exact circumstances at the time of the reported event are unknown.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: 02/2024).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.

• Brand Name: NAVARRE UNIVERSAL DRAIN
• Type of Device: 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: 13234811
• MDR Text Key: 283951651
• Report Number: 3006260740-2021-05627
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741037009
• UDI-Public: (01)00801741037009
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K951475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NNU8LPT
• Device Catalogue Number: NNU8LPT
• Device Lot Number: GFFP0460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1