MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NAVARRE OPTI DRAIN 12F PIGTAIL; CHRONIC CATHETERS

Catalog Number NOD12PT

Device Problems Crack (1135); Fracture (1260)

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

Event Date 10/14/2020

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 been returned to the manufacturer for evaluation.However, a photo is provided for a review.The investigation of the reported event is currently underway.(expiry date: 07/2021).

Event Description

It was reported that post catheter placement, the device allegedly had crack on hub.The procedure was completed using another device.There was no patient injury.

Event Description

It was reported that post catheter placement, the device allegedly had crack on hub.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one navarre catheter in two segments was returned for evaluation.Gross, microscopic visual and functional testing were performed.Based on the sample evaluation, the investigation is confirmed for crack on hub issue as a complete compound break was noted to the hub starting from the distal end of the strain relief.A crack on the hub was also observed from the most proximal end and extended down to approximately one third of the outer hub.However, the proximal pieces of the hub were not returned.The device appeared to roll and pigtail with no issues.The strain relief was pulled proximally over the exposed wire and was able to lock the wire into place with no issue and kinks were noted at three of the drainage holes when the device was pig tailed.Based on the photo review, the investigation is inconclusive for the crack on hub issue as the reported issue cannot be confirmed from the provided photo.A definitive root cause could not be determined.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: 07/2021), g4.H11: f6 (device), h6 (results, conclusion) 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.

• Brand Name: NAVARRE OPTI DRAIN 12F PIGTAIL
• Type of Device: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10807088
• MDR Text Key: 215282241
• Report Number: 3006260740-2020-20428
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NOD12PT
• Device Lot Number: GFCT2346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other