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

Model Number	000702
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2018
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.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 the cap of the large port of the feeding adapter became loose a few days after placement.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a lot history review, a dhr review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one feeding tube bifurcation adaptor was returned for evaluation.Functional/visual and dimensional evaluations were performed.The investigation is confirmed for a loose cap as when backpressure was applied to the sample, the main cap dislodged easily.No leaks were noted on the small port.The large port inner diameter was found to be somewhat above specification.No obvious damage was apparent from the sample evaluation photo.The definitive root cause could not be determined based upon available information.However, possible causes of such an event may include insufficient insertion of the port plug, excessive force on the plug during insertion, and wear/deformation over time.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.
Event or Problem Description
It was reported that the cap of the large port of the feeding adapter became loose a few days after placement.There was no reported patient injury.

• 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: 7718770
• Report Number: 3006260740-2018-01822
• Device Sequence Number: 996345
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1