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

Model Number NOD10LPT

Device Problem Fracture (1260)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, two photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022).Device pending return.

Event Description

It was reported that some time post drainage catheter placement, the catheter allegedly had a crack.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that some time post drainage catheter placement, the catheter allegedly had a crack.The procedure was completed using another device.There was no reported patient injury.

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: one sealed 10f navarre drainage catheter locking pigtail segment was returned for evaluation.Gross visual evaluation were performed.In addition to the returned physical sample, one electronic photo was provided for review.During visual evaluation of the returned lot sample no anomalies were noted on the components within the sealed package.However, the investigation is confirmed for the reported fracture issue as crack was noted on the hub of the drainage catheter.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: 08/2022).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 : see h10.

Manufacturer Narrative

H10: only one device was involved in this reportable event at the user facility.Additional unused lot sample from the same lot/product catalog number were returned from the customer for evaluation and investigation of this event.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 sealed 10f navarre drainage catheter locking pigtail segment was returned for evaluation.Gross visual evaluation were performed.In addition to the returned physical sample, one electronic photo was provided for review.During visual evaluation of the returned lot sample no anomalies were noted on the components within the sealed package.However, the investigation is confirmed for the reported catheter hub fracture issue as crack was noted on the hub of the drainage catheter in the provided photo.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: 08/2022), g3, h6 (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 some time post drainage catheter placement, the catheter allegedly had a crack.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: NAVARRE OPTI 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: 15452953
• MDR Text Key: 306160177
• Report Number: 3006260740-2022-03650
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741037030
• UDI-Public: (01)00801741037030
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: UNKNOWN
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOD10LPT
• Device Catalogue Number: NOD10LPT
• Device Lot Number: GFDU3972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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