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

Catalog Number	M120100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
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 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 complications with the powerglide catheter was confirmed and the damage appears to be use related.One 20ga powerglide catheter and deployment system were returned for investigation.The returned sample revealed evidence of use.Blood residue was observed throughout the sample.The guidewire had been fully extended and the guidewire push-off button had separated from the housing.The catheter and catheter wings were received over the needle and had not been fully removed from the needle.The distal tip of the needle was located 2.8cm distal to the pink strain relief sleeve.The catheter extended 7.2 cm from the distal tip of the needle.A 2mm gap was observed between the proximal end of the purple catheter hub and the adjoining surface on the catheter handle, which indicates that an attempt was made to remove the catheter from the handle while the catheter was over the needle.The sequence of insertion steps in the ifu includes gripping the plastic housing and advancing the catheter using the catheter handle, holding the catheter in place using the catheter handle and fully removing the housing, and then twisting and removing the catheter handle from the catheter hub.A microscopic examination of the catheter revealed blood residue in the catheter.Slits in the catheter were located 1 cm and 1.3 cm distal to the position of the needle tip within the catheter.Fluid was able to leak from the slits in the catheter.The tubing was most likely damaged with the needle during use.The product ifu warns, ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.This may result in damage to the catheter.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ the ifu also states, ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.¿ the observed damage and reported complications appear to be related to use of the device.A lot history review (lhr) of reaz1327 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales rep, the facility reported that the rn could not disconnect the housing from the catheter.It was stated that the rn felt resistance when trying to remove the complete device (housing, catheter, and wire) from the patient.

• Brand Name: POWERGLIDE MIDLINE CATHETER 20G, 10CM W/ 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: 6589384
• Report Number: 3006260740-2017-00682
• Device Sequence Number: 19042106
• Product Code: FOZ
• UDI-Device Identifier: 00801741075322
• UDI-Public: (01)00801741075322(17)181231(10)REAZ1327
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• 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
• Report Date (Section B): 05/24/2017

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: 12/31/2018
• Device Catalogue Number: M120100
• Device Lot Number: REAZ1327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1