MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F; FEEDING AND DECOMPRESSION TUBES

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 by the patient that she had a g-tube placed on friday, (b)(6) 2017 to replace her prior peg tube.She states that the extension tube has a leak in it and it is leaking all over.She states it is leaking from the actual tube, not where the bag attaches to the tube, and not the opening.Patient would like the extension tube portion of the device replaced not the entire device.Patient was advised to contact physician.
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 leak in the continuous feeding tube was confirmed, and the damage appeared to be supplier related.One 18fr x 90-degree continuous feeding tube was returned for investigation.A microscopic examination of the female vinyl connector revealed gap at the location of the injection molding gate.With a syringe fully inserted into the proximal end of the connector, the continuous feeding tube was flushed and pressurized with water, but no leaks were identified.The syringe tip was positioned distal to the gap at the injection molding gate and was sealing off the leak path.The syringe was partially removed, which revealed fluid leaking from the connector.The investigation findings were forwarded to the manufacturing facility for further review.11/16/2017: based on photo received, the complaint is confirmed.A gap is observed at the location of the injection molding gate.A supplier quality alert was issued to the supplier.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 by the patient that she had a g-tube placed on friday, (b)(6) 2017 to replace her prior peg tube.She states that the extension tube has a leak in it and it is leaking all over.She states it is leaking from the actual tube, not where the bag attaches to the tube, and not the opening.Patient would like the extension tube portion of the device replaced not the entire device.Patient was advised to contact physician.

• Brand Name: BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F
• Common Device Name: FEEDING AND DECOMPRESSION TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6960104
• Report Number: 3006260740-2017-01853
• Device Sequence Number: 1142510
• Product Code: KGC
• UDI-Device Identifier: 00801741080821
• UDI-Public: (01)00801741080821
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 000256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Event Location: Home
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR