MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD PEG SAFETY SYSTEM - "GUIDEWIRE" (20F); TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	006036
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2018
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 that when kit was opened, the guidewire was noted to be damaged.No other information was provided.There was no patient injury reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 defective guidewire is confirmed and the cause is determined to be likely use-related.The device was found during preliminary evaluation to be one a damaged 260 cm ptfe-coated guidewire with its plastic hoop dispenser.Visual observation found that the guidewire was mostly within the hoop, but was partly unraveled and the core wire was broken at one end.The uncoiling of the coil wire appeared to begin less than 5 cm from the exposed end of the wire.The wire did not appear constrained within the dispenser.Microscopic evaluation found that the flat core wire had broken at the distal weld tip.Tapering was noted at both ends of the break.The core wire was somewhat twisted near the break.The physical characteristics of this break are consistent with a tensile failure resulting from constraining the wire, such as against a needle tip, and then pulling on the wire.This is consistent with the statement in the complaint description that the event occurred during use.While the exact cause is not known, possible causes include attempt to remove guidewire from hoop before removing the retaining plug from the hoop, rapid/forceful removal of the guidewire from the hoop, and damage from unknown causes prior to use.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 that when kit was opened, the guidewire was noted to be damaged.No other information was provided.There was no patient injury reported.

• Brand Name: BARD PEG SAFETY SYSTEM - "GUIDEWIRE" (20F)
• 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: 7438554
• Report Number: 3006260740-2018-00726
• Device Sequence Number: 16417603
• 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): 06/07/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1