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

Model Number	006035
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided, a manufacturing review will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 01/2021).
Event or Problem Description
It was reported that upon unpacking the feeding device package, the guidewire was allegedly found missing in the package prior to use on patient.There was no patient contact.
Event or Problem Description
It was reported that upon unpacking the feeding device package, the guidewire was allegedly found missing in the package prior to use on patient.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was provided and a lot history review was performed.Investigation summary: as received, one peg tube, one external bolster, one curved hemostat, four gauze strips, two scissors, two safety needles, one pinch lamp, one external star bolster, one insertion wire, one safety scalpel, and one dual port feeding adapter.The insertion wire was partially inserted into to the guidewire hoop to optimize packaging.Components were compared against content list and the guidewire, gauze, both safety needles (21g and 25g), 5 ml syringe, drape, and snare were missing.The investigation remains inconclusive due to the fact that the kit components were returned out of the package and the kit had been opened.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiration date: 01/2021), g4.H11: b5, d1, d2, h3, h6 (results, conclusions).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: PEG SAFETY 20FR PULL
• 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: 9712144
• Report Number: 3006260740-2020-00529
• Device Sequence Number: 19626047
• 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): 07/23/2020

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: HUDV0516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1