MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX, 20G 8CM BASIC KIT (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Model Number	F120080
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebp1302 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that during placement of the powerglide pro the catheter and the wire became severed/disconnected.The wire and the catheter were removed from the patient and the procedure was stopped.No injury to the patient was reported.
Additional Manufacturer Narrative
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 break in the guidewire was confirmed, and the damage appears to be related to use of the device.One 20g x 8cm powerglide pro and deployment system were returned for investigation.The catheter was positioned over the needle.The distal 3.6cm segment of guidewire was received separate from the needle and deployment system.The guidewire push-off button was in the retracted position.No portion of the guidewire was protruding from the distal tip of the needle.A microscopic examination of the returned sample revealed residue between the needle and the catheter, which indicates that the product was used.A 4mm segment of wire was observed between the distal tip of the catheter and the needle shaft.The fractured end of the wire exhibited necking and a granular tip, which is consistent with a tensile break.The heel of the of the needle bevel exhibited deformation, which is indicative of force between the wire and the needle bevel.Forcing the wire against the heel of the needle bevel can cause the guidewire to break.The guidewire should be fully retracted in the needle before insertion.A longitudinal slit in the tubing was observed approximately 1cm from the distal tip of the catheter, which was determined to be from the needle.It appears that the guidewire and catheter were damaged against the needle tip.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.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebp1302 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that during placement of the powerglide pro the catheter and the wire became severed/disconnected.The wire and the catheter were removed from the patient and the procedure was stopped.No injury to the patient was reported.

• Brand Name: PFLEX, 20G 8CM BASIC KIT (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: 6835163
• Report Number: 3006260740-2017-01467
• Device Sequence Number: 68183
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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 Model Number: F120080
• Device Catalogue Number: F120080
• Device Lot Number: REBP1302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1