MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NBR GASTROSTOMY TUBE 20F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000702
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images 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.The device has 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 damage at the distal end of the obturator was found at the time of opening the package.There was no reported patient involvement.
Event or Problem Description
It was reported that damage at the distal end of the obturator was found at the time of opening the package.There was no reported patient involvement.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Investigation summary: one ponsky nbr 20f non-balloon replacement obturator was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective accessory , as it was noted that distal and proximal ends of obturator showed excess material.The definitive root cause was determined to be supplier related where the flash from the molded parts was not removed after processing.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.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: PONSKY NBR GASTROSTOMY TUBE 20F
• 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: 7782267
• Report Number: 3006260740-2018-02058
• Device Sequence Number: 1793594
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103109
• 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): 05/16/2019

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: Health Professional
• Device Model Number: 000702
• Device Catalogue Number: 000702
• Device Lot Number: REBZ0337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1