MAUDE Adverse Event Report: C.R. BARD, INC.; TUBE, FEEDING

Lot Number NGBR3192

Device Problems Defective Device (2588); Malposition of Device (2616); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  malfunction  

Event Description

The patient had been struggling with breastfeeding her baby multiple times during the rn's shift.Prior to rn's shift, the nurse or lactation consultant had set the patient up with both a nipple shield, a tube, and syringe to assist her in feeding her newborn.After multiple attempts to set it up correctly, the rn had noticed the newborn was still unable to suck down the supplemental formula from the tube and syringe at her breast.Upon further inspection of the five french tube that is used; rn saw that this particular tube was defective.Normally the tube that we use is supposed to have two separate holes at the end, so that if its in the infant's mouth one hole is pressed up against her cheek or the roof of her mouth, she is still able to suck the supplemental formula from the other hole that should be open.The tube that the patient had been given only had one hole.I believe it was probably pressed against the infant's cheek or roof of her mouth, so the infant was not able to suck any supplemental formula out of it.

• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): C.R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 7285342
• MDR Text Key: 100643940
• Report Number: 7285342
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: NGBR3192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1