MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD PEG SAFETY SYSTEM - "GUIDEWIRE" (20F); PEGS

Model Number	006036
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2017
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) of hubn1321 showed one other similar product complaints from this lot number.
Event or Problem Description
It was reported by the facility that the guidewire was damaged.Sales rep stated the guidewire was stuck in the "holder".No other information provided.No patient injury reported.On 02/01/2018, returned sample found core wire of the guidewire was broken.
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 guidewire is confirmed; however the cause is unknown.One 260 cm guidewire in a blue plastic hoop was returned for evaluation.An initial visual observation showed a slight bend in the guidewire approximately 23 cm proximal to the distal weld tip.No obvious evidence of use was observed.The core wire was observed to be detached from the distal weld tip.A microscopic observation revealed the distal weld tip was present and intact.The coiled wire was observed to be slightly unraveled beginning approximately 15 cm proximal to the distal weld tip and ending approximately 42 cm proximal to the distal weld tip.The break site was found to be tapered and the break surface was observed to be granular in texture, which is evidence of a tensile failure.Resistance was felt when attempting to remove the guidewire from the hoop and the guidewire was observed to stretch when pulled on due to the broken core wire.While the exact cause of the damage observed in the returned sample is unknown, possible causes include attempt to remove guidewire from hoop before removing the retaining plug from the hoop and rapid/forceful removal of guidewire from hoop.A lot history review (lhr) of hubn1321 showed one other similar product complaints from this lot number.
Event or Problem Description
It was reported by the facility that the guidewire was damaged.Sales rep stated the guidewire was stuck in the "holder".No other information provided.No patient injury reported.02/01/2018-returned sample found core wire of the guidewire was broken.

• Brand Name: BARD PEG SAFETY SYSTEM - "GUIDEWIRE" (20F)
• Common Device Name: PEGS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7289985
• Report Number: 3006260740-2018-00262
• Device Sequence Number: 1066570
• Product Code: KNT
• UDI-Device Identifier: 00801741081194
• UDI-Public: (01)00801741081194
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: 006036
• Device Catalogue Number: 006036
• Device Lot Number: HUBN1321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1