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

Model Number	000702
Medical Device Problem Codes	Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
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 has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that a foreign material was attached to the cap, at the tip of the obturator.There was no reported patient injury.
Event or Problem Description
It was reported that a foreign material was attached to the cap, at the tip of the obturator.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: per the lot history review, this is the first complaint reported for this lot number and issue to date.The quantity affected is one.Based upon the severity level and lot quantity, a dhr review is not required.However, the dhr was requested to review manufacturing records.Investigation summary: one ponsky nbr obturator was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for specific failure mode, as the sample obturator was received with some flash was observed on the protective plastic tip.The definitive root cause was determined to be supplier related where the flash from the molded parts was not removed after processing.The complaint due to ¿foreign material was attached to the cap¿ was confirmed.According to the photo visual evaluation performed and bpv investigation was conclude that the obturator had an excess of material apparent flash and since this is a supplied component, the cause of this condition is 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) showed that the product labeling is adequate.
Event or Problem Description
It was reported that a foreign material was attached to the cap, at the tip of the obturator.There was no reported patient injury.
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 has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

• 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: 8001868
• Report Number: 3006260740-2018-03014
• Device Sequence Number: 1311831
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2019

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: RECR1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 05/22/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 01/08/2019; 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1