MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PFLEX, 18G 10CM FULL (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Catalog Number	F118101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 rebn0554 showed one other similar product complaint from this lot number.
Event or Problem Description
Per clinical specialist the rn at the facility reported he pulled the wire back, went to stick and couldn't get the needle in the skin, then checked and the wire was slightly deployed.The rn stated that he tried to pull the wire back and it "fell inside" the device.This file address the second device.
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 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, but the cause remains unknown.The sample returned consisted of two photographs, each of a powerglide pro device reportedly a pflex, 18g 10 cm full w/ guardiva set.Visual observation found the first photograph to show the powerglide pro with the guidewire not extending out of the needle, although the guidewire slider was moved forward, the catheter not deployed, and the catheter wings in a proximal position.The second photograph shows a powerglide device from the side, with the wings in the proximal position and the catheter not deployed.The guidewire carriage component within the device was not visible, suggesting it was advanced forward; however, the wire was found far towards the back of the device, indicating it was not properly seated in the carriage.It is not known how the guidewire became improperly situated, but the report states that when insertion was attempted and could not be completed, the device was examined and it was found that the guidewire was, at that time, partially deployed out of the needle.Therefore, it is reasonable to believe that the wire was caught between the needle and the skin, preventing insertion.If, during insertion, pressure continued to be applied to the guidewire slider, the guidewire may have bowed such that it was pushed out of the guidewire carriage.This would explain why, when retrograde guidewire motion was then attempted, the guidewire retreated fully into the device.Alternatively, the guidewire may have been out of place when the procedure began.The sequence of events is not known, and therefore the cause is unknown.

• Brand Name: DOT PFLEX, 18G 10CM FULL (POWERGLIDE PRO)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6446595
• Report Number: 3006260740-2017-00339
• Device Sequence Number: 1378536
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566(17)180228(10)REBN0554
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: F118101
• Device Lot Number: REBN0554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1