MAUDE Adverse Event Report: BARD ACCESS SYSTEMS CONTINUOUS FEEDING TUBE 24F; FEEDING AND DECOMPRESSION TUBES

Model Number 000258

Device Problems Hole In Material (1293); Unsealed Device Packaging (1444); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of hubt1737 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that when the package was opened they alleged a possible issue with the product molding; they noticed what appeared to look like a pin hole by the "bell shape" on the tube.Device was not used on patient.

• Brand Name: CONTINUOUS FEEDING TUBE 24F
• Type of Device: FEEDING AND DECOMPRESSION TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6956478
• MDR Text Key: 89616414
• Report Number: 3006260740-2017-01839
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00801741080845
• UDI-Public: (01)00801741080845
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000258
• Device Catalogue Number: 000258
• Device Lot Number: HUBT1737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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
• Patient Age: 44 YR