MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PULL DELUXE PEG 20F; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number	000792
Health Effect - Clinical Code	Weight Changes (2607)
Date of Event	07/06/2016
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of huaq1229 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 1/27/17 - per medwatch form, facility reported that the peg migrated out of its internal position on day 5, post placement.The placement was confirmed visually using a scope to ensure the gastric bumper was in place, following the application of the external bumper.The tube was well anchored externally, the external placement was not mobile.Patient was receiving plasmapheresis and had fluid weight gain during this time.The nurse did not report any tugging or pulling on the line during care.Tube feeds were not started until day 3.Patients upper extremities are very limited due to transeverse myelitis.No patient injury was reported.

• Brand Name: PULL DELUXE PEG 20F
• Common Device Name: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6341050
• Report Number: 3006260740-2017-00099
• Device Sequence Number: 552486
• Product Code: KNT
• UDI-Device Identifier: 00801741081132
• UDI-Public: (01)00801741081132(17)180228(10)HUAQ1229
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/24/2017
• Report Date (Section F): 01/09/2017

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 000792
• Device Lot Number: HUAQ1229
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/09/2017