MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO) INTRAVASCULAR CATHETER

Model Number F120100

Device Problem Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

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 damaged powerglide was confirmed and the cause appeared to be use-related. The product returned for evaluation was one 20ga x 10cm powerglide pro assembly. The sample was received assembled with the catheter overlaying the introducer needle. Usage residue were observed throughout the catheter and the needle. The guidewire extended through the needle and the catheter. The needle perforated the catheter. The inner core wire was broken and the outer coil wire was elongated. Microscopic inspection wire confirmed that the inner wire was broken and the outer was elongated. The weld tip was intact. The elongated region appeared to be confined to the region of wire within the needle. The catheter and guidewire damage were consistent with withdrawal against the needle bevel during attempted insertion. The product ifu states ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle. 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. ¿ a lot history review (lhr) of rebt1468 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to sales rep that after multiple unsuccessful attempts to place the catheter the physician decided to remove the guidewire and attempt to place the device in a different location. When attempting to remove the guidewire the physician met resistance, he continued to try and remove the guidewire but it was stated that the guidewire "got stuck. " the guidewire wouldn't come out until the physician used "excessive force" and then "everything was pulled out of the patient's arm. " no patient injury reported.

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 rebt1468 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to sales rep that after multiple unsuccessful attempts to place the catheter the physician decided to remove the guidewire and attempt to place the device in a different location. When attempting to remove the guidewire the physician met resistance, he continued to try and remove the guidewire but it was stated that the guidewire "got stuck. " the guidewire wouldn't come out until the physician used "excessive force" and then "everything was pulled out of the patient's arm. " no patient injury reported.

• Brand Name: PFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7117021
• MDR Text Key: 188749705
• Report Number: 3006260740-2017-02228
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110535
• UDI-Public: (01)00801741110535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Model Number: F120100
• Device Catalogue Number: F120100
• Device Lot Number: REBT1468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial