MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 18G, 8CM BASIC TRAY; INTRAVASCULAR CATHETER

Catalog Number	M118080
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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 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 detached guidewire was confirmed but the exact cause was unknown.The item submitted for evaluation was a photograph of a powerglide midline catheter.The product packaging, catheter delivery system, and a loose guidewire were shown in the image.Blood-like residue could be seen on the delivery system which indicated product use and the guidewire was slightly bent at both ends.A review of the manufacture quality and inspection records for the implicated product lot found no potentially related issues during manufacture of the device.Assessment of observations obtainable in the photograph was not enough to determine the potential root cause of the separated guidewire.Should the physical device be returned for evaluation the root cause investigation will be reopened and further evaluation will be performed at that time.A lot history review (lhr) of reaq0668 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
As reported by the facility, the wire in the powerglide pro came off and had to be removed from the patient.

• Brand Name: POWERGLIDE MIDLINE CATHETER 18G, 8CM BASIC TRAY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6356789
• Report Number: 3006260740-2017-00151
• Device Sequence Number: 1200097
• Product Code: FOZ
• UDI-Device Identifier: 00801741038082
• UDI-Public: (01)00801741038082(17)180228(10)REAQ0668
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2017

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: 02/28/2018
• Device Catalogue Number: M118080
• Device Lot Number: REAQ0668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1