MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NBR GASTROSTOMY TUBE 20F (EXPORT ONLY); REPLACEMENT G-TUBES

Model Number	000702
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the internal dome fell into the patient's stomach.The dome was retrieved with a snare.No patient injury was reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a broken retention dome was confirmed, but the cause of the damage was unknown.One 20 fr ponsky non-balloon replacement tube was returned for investigation.Evidence of use was observed on the returned sample.Residue was observed within the gastrostomy tube and the dual port feeding adaptor.The dome material was discolored.The color varied from yellow to dark brown.A separation of the dome material from the peg tube was observed.A portion of the dome material remained attached to the tube.It is possible that excessive force was applied during insertion and/or removal of this device and that the dome material was weakened or stretched beyond its elastic limits.The angle of removal could also be a potential contributing factor.The complainant indicates the retention dome broke when exchanging the feeding tube.The product ifu provides the following guidance to prevent damage to the tube during removal.During the traction removal procedure, pull the catheter parallel to the stoma tract.Do not pull catheter laterally at an acute angle to the stoma tract.Doing so will apply a force greater than intended for the design and may result in damage to or separation of the dome.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
Event or Problem Description
It was reported that the internal dome fell into the patient's stomach.The dome was retrieved with a snare.No patient injury was reported.

• Brand Name: PONSKY NBR GASTROSTOMY TUBE 20F (EXPORT ONLY)
• Common Device Name: REPLACEMENT G-TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6944668
• Report Number: 3006260740-2017-01824
• Device Sequence Number: 1460245
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 000702
• Device Catalogue Number: 000702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1