MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000714
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.Photographs have been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that the product code and the lot number do not match the product description.The device was not used.There was no patient involvement.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Investigation summary: one sealed white cardboard carton with foreign character labeling and three photographs of a similar carton were returned for evaluation.Visual evaluations were performed.The investigation is confirmed for mislabeling, as the printed text on the carton was inconsistent with the label on the carton, the pouch label inside, and the product inside the pouch.The photographs were consistent with the returned carton.The root cause of the mislabeling is determined to be supplier-related.Labeling review: because this complaint is manufacturing related, a review of product labeling documents is not applicable.Product labeling, such as indications, warnings, precautions, cautions, possible complications, and contraindications, would not have prevented this issue.
Event or Problem Description
It was reported that the product code and the lot number do not match the product description.The device was not used.There was no patient involvement.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 14F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7720112
• Report Number: 3006260740-2018-01834
• Device Sequence Number: 13702146
• Product Code: KNT
• UDI-Device Identifier: 00801741037122
• UDI-Public: (01)00801741037122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 000714
• Device Catalogue Number: 000714
• Device Lot Number: NGCQ4386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1