MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,16F; FEEDING DEVICE

Model Number	000716
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2021).
Event or Problem Description
It was reported that prior to the gastrostomy tube placement procedure, the physician allegedly noticed the printing error of the device's outer package.The top of the outer package was orange and the sides of the package were yellow, although 16fr is supposed to be orange.There was no reported patient contact.
Event or Problem Description
It was reported that prior to the gastrostomy tube placement procedure, the physician allegedly noticed the printing error of the device's outer package.The top of the outer package was orange and the sides of the package were yellow, although 16fr is supposed to be orange.There was no patient contact.
Additional Manufacturer Narrative
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 tri-funnel replacement gastrostomy tube was returned for evaluation and one electronic photo was provided for review.Visual evaluation was performed on the returned device.The investigation is confirmed for the reported device markings/labelling problem as the printed label on the top of the outer carton box packaging was orange in color whereas the printed label on the side of the packaging box was yellow in color, further the photo review also confirms the same.The definitive root cause could not be determined based upon 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: 06/2021).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.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE,16F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11548509
• Report Number: 3006260740-2021-00941
• Device Sequence Number: 11813228
• Product Code: KNT
• UDI-Device Identifier: 00801741037139
• UDI-Public: (01)00801741037139
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: Health Professional
• Device Model Number: 000716
• Device Catalogue Number: 000716
• Device Lot Number: NGCN0404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other