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

Model Number	000702
Medical Device Problem Codes	Fitting Problem (2183); Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2018
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 not provided, a review of the device history records could not be performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the cap on the dual port feeding adapter did not close well and stuck tight.There was no reported patient involvement.
Event or Problem Description
It was reported that the cap on the dual port feeding adapter did not close well and stuck tight.There was no reported patient involvement.
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.
Additional Manufacturer Narrative
Manufacturing review: the lot met all release criteria.Manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.This is the 1st complaint reported for this lot number and issue to date.Investigation summary: one 20fr ponsky nbr tube was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for a loose cap, more specifically one caused by a molding issue.Flash was observed on both hub caps.No signs of use were observed throughout the sample.This flash would cause significant difficulty in placing the caps in the ports.The root cause for this event has been determined to be supplier related.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) is not applicable since this complaint was found to be supplier-related.Labeling would not have prevented this issue.(expiry date 11/2021).
Event or Problem Description
It was reported that the cap on the dual port feeding adapter did not close well and stuck tight.There was no reported patient involvement.

• 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: 7997307
• Report Number: 3006260740-2018-02985
• Device Sequence Number: 18904510
• 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,Followup
• Report Date (Section B): 06/03/2019

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: RECS1773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 05/23/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 01/08/2019; 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1