MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG SAFETY 20FR PULL, MEDICON; FEEDING TUBE

Model Number	006035
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420); Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lot history review was completed and identified that this is the first reported complaint for this lot number and this issue to date.The device has been returned to the manufacturer for evaluation.A photo has been provided for review.The investigation of the reported event is currently underway.(expiration date: 01/2021).
Event or Problem Description
It was reported that some time post gastrostomy feeding tube placement, the cap of the feeding tube adapter was allegedly unable to close properly due to fins remained in the cap caused an alleged leak.There was no reported patient injury.
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 feeding tube adapter was received for evaluation.Gross examination of the feeding tube adapter showed fins of the same material remaining on the cap.The investigation is confirmed for the alleged fitting issue as well as the leak that this fitting issue would cause if infused.An electronic photo was also reviewed confirming the findings from sample evaluation.The root cause has been determined to be manufacturing related.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.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.
Event or Problem Description
It was reported that some time post gastrostomy feeding tube placement, the cap of the feeding tube adapter was allegedly unable to close properly due to fins remained in the cap caused an alleged leak.There was no reported patient injury.

• Brand Name: PEG SAFETY 20FR PULL, MEDICON
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9941125
• Report Number: 3006260740-2020-01221
• Device Sequence Number: 2900408
• Product Code: KNT
• UDI-Device Identifier: 00801741081187
• UDI-Public: (01)00801741081187
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915841
• 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): 10/02/2020

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: 006035
• Device Catalogue Number: 006035
• Device Lot Number: HUDV0521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR