MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 20G 10CM; INTRAVASCULAR CATHETER

Catalog Number	M120100
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/07/2016
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezi0872 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 4/19/16 - complainant reported that a the wire from a 20g x 10cm midline catheter frayed.They stated that the wire seemed to uncoil and then fray.The physician did not pull the wire back into the needle because once he felt resistance, he did not go any farther.The patient was not harmed or injured.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 20G 10CM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5648812
• Report Number: 3006260740-2016-00219
• Device Sequence Number: 13526392
• Product Code: FOZ
• UDI-Device Identifier: 00801741075322
• UDI-Public: (01)00801741075322(17)170828(10)REZI0872
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2016

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: 07/31/2017
• Device Catalogue Number: M120100
• Device Lot Number: REZI0872
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1