MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG SAFETY 20FR PULL, MEDICON; TUBES, GATROINTESTINAL (AND ACCESSORIES)

Model Number	006035
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that the depth markings allegedly were not printed on the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history record review could not be completed as the lot number was not provided.Investigation summary: one non-balloon gastrostomy tube was received for evaluation.Visual evaluations were performed.Wear was noted to markings on the catheter near the distal end of the catheter.Blood and residue were noted throughout.It is unknown if the wear on the markings was due to use or if it was due to a failure in manufacturing.The investigation is inconclusive due to the use that the device saw and the possible relationship this could have had on the alleged failure mode.A definitive root cause could not be determined.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 the depth markings allegedly were not printed on the catheter.There was no reported patient injury.

• Brand Name: PEG SAFETY 20FR PULL, MEDICON
• Common Device Name: TUBES, GATROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9398259
• Report Number: 3006260740-2019-03728
• Device Sequence Number: 17009699
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1