MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING DEVICES, SAFETY

Model Number	006035
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided, therefore, the device history records were not reviewed.A photo of the device was provided and is pending evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that after the percutaneous endoscopic gastrostomy tube was placed, the tube was found damaged.It was further reported that the tube was repaired and remains in the patient.There was no reported patient injury.
Event or Problem Description
It was reported that after the percutaneous endoscopic gastrostomy tube was placed, the tube was found damaged.It was further reported that the tube was repaired and remains in the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a dhr review was not performed as no product lot number was provided by the complainant.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for damaged catheter, as the photo shows a portion of the silicone feeding tube between hands.It shows a partial break in the peg feeding tube near the "20f" lettering.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Possible contributing factors include damaged during implantation, sharp instrument damage, and excessive force.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.The information provided by bd 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 bd.

• Brand Name: PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING DEVICES, SAFETY
• Common Device Name: FEEDING
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8199991
• Report Number: 3006260740-2018-03747
• Device Sequence Number: 1557612
• Product Code: KNT
• UDI-Device Identifier: 00801741081187
• UDI-Public: (01)00801741081187
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: 006035
• Device Catalogue Number: 006035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1