MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEGS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000627
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records (dhr) review showed component acceptability and traceability were confirmed through incoming inspection records for traceable components used.Product lot passed all required inspections at both end product and subassembly levels.No manufacturing issues associated to the reported event were found in the reviewed lot.A sample evaluation could not be performed as the samples were not returned.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000627 tubes, gastrointestinal (and accessories) allegedly did not present adequate durability and there was a need to exchange an external part.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• Brand Name: PEGS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8813846
• Report Number: 3006260740-2019-02086
• Device Sequence Number: 2562845
• Product Code: KNT
• UDI-Device Identifier: 00801741081071
• UDI-Public: (01)00801741081071
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: No Information
• Device Model Number: 000627
• Device Catalogue Number: 000627
• Device Lot Number: HUBX2521
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1