MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NBR 20 FR REPLACEMENT BUMPER; REPLACEMENT G-TUBES

Model Number	000702
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
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 cap of the side port would not close and that a little fraction of the solution injected into the stomach would reflux through the side port.No patient injury was reported.
Additional Manufacturer Narrative
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 damaged dual port feeding adaptor was confirmed, but the exact cause is unknown at this time.One ponsky replacement gastrostomy tube was returned for investigation.Residue was observed on the returned product, which confirms that the product was used.A longitudinal tear was observed in the small port adjacent to the strap, which affected the retention properties between the plug and port.A microscopic examination revealed what appeared to be adhesive that may have been used to repair the tear.The surface of the tear was granular.It is unknown how the material was torn, but may have occurred during use.While the tear was most likely the cause of the reported event, it was observed that the average outside diameter (od) of the small plug was below specification.It is unknown if this was a contributing factor in the reported event; nevertheless, the complaint sample was forwarded to the manufacturing facility to address the plug that was out of specification.09/19/2017: the sample was removed from the polybag and physically evaluated.During visual inspection without magnification, a partial tear in the small port adjacent to the strap was observed.In the torn area remnants of a foreign matter, appearing to be some type of adhesive was observed, may have been used to repair the tear.Per measurements taken, all dimensions of the complaint sample were within specification, except the small plug od.The small plug was below specification; it is unknown if this could have contributed to the reported complaint.A supplier quality alert (sqa # 43-17-073) was issued to the two (2) port adapter supplier (alps silicone manufacturing llc).A functional test was performed to confirm interference fit on both ports of the adapter.An interference fit was confirmed for both ports.Both ports were closed and they remained closed, therefore the complaint for ¿cap of the side port would not close¿ could not be confirmed.The observed tear in the small sport of the two (2) port adapter is likely the cause of the reported event.It was observed that the outside diameter (od) of the small plug was below specification, but it is unknown if this was a contributing factor in the reported event.The complaint could not be confirmed for the reported complaint that the cap of the side port would not close, however it is confirmed for leakage in the torn area.The complaint could not be confirmed as manufacturing related.The root cause of the complaint is determined as unknown.E.Ramos 09/19/17.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 cap of the side port would not close and that a little fraction of the solution injected into the stomach would reflux through the side port.No patient injury was reported.

• Brand Name: PONSKY NBR 20 FR REPLACEMENT BUMPER
• Common Device Name: REPLACEMENT G-TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6765688
• Report Number: 3006260740-2017-01215
• Device Sequence Number: 1412043
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PRM 61090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1