MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PFLEX, 20G 8CM FULL W/O GIVA (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Catalog Number	F220081
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
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, at this time, for evaluation.A lot history review (lhr) of (b)(4) showed one other similar product complaint(s) from this lot number.The complaints for this lot number ((b)(4)) have been reported from the same facility.Device not yet returned for evaluation.
Event or Problem Description
Per medwatch form, the facility reported that they placed a powerglide midline catheter with the seldinger technique.Upon pulling the wire back to remove it, there was resistance felt.The healthcare professional (hcp) removed the catheter itself to see if that would help pull the wire out but the wire would not come out of the patient's arm.Ultrasound indicated that the wire was outside the vein.An x-ray was done and showed the wire inside the arm.Patient was taken to radiology for removal.It was reported that the wire was unraveled upon removal.

• Brand Name: DOT PFLEX, 20G 8CM FULL W/O GIVA (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: 6350779
• Report Number: 3006260740-2017-00119
• Device Sequence Number: 10970190
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528(17)180131(10)REAU1896
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• 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): 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: F220081
• Device Lot Number: REAU1896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/30/2016
• 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: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 78
• Date Report Sent to FDA: 12/15/2016