MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PFLEX, 18G 10CM FULL W/O GIVA (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Model Number	N/A
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 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 damaged guidewire was confirmed, and the damage appears to be associated with use of the device.One powerglide pro was returned for investigation.The catheter was located on the needle.The guidewire push-off button was extended, but was not in the fully extended position.The section of guidewire that extended from the needle was damaged.The coil wire was unraveled over the core wire.A break in the core wire was observed 4.5mm from the distal weld tip.A microscopic examination of the broken ends of the core wire revealed granularity near the center of the core wire.A portion of the outside edge exhibited increased luster at the broken ends of the core wire.The heel of needle bevel was damaged.The damage observed is consistent with the reported event.The complainant reported that they believed that the needle was inserted with the wire slightly extended.This would put force the wire against the heel of the needle bevel, which most likely caused the core wire to break.A break in the core wire would allow the coil wire to unravel over the core wire.The guidewire should be fully retracted in the needle before insertion.A lot history review (lhr) of rebq0171 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per clinical specialist, the facility reported that during placement of the device, the needle pierced and went in under the skin, but not into the vessel.It was stated that as the nurse went to push the catheter in, there was resistance, a pop was heard and the rn went to pull it back and the guidewire had barbed.The rn then uncoiled it and the whole thing came out.He stated that the internal wire had been cut when the needle accessed the skin and the wire might have been slightly extended.The nurse called the physician who stated that they did not need to do an x-ray; the nurse had palpated and couldn¿t feel anything inside the patient.A new catheter was placed.No patient injury was reported.

• Brand Name: DOT PFLEX, 18G 10CM FULL W/O GIVA (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: 6605862
• Report Number: 3006260740-2017-00696
• Device Sequence Number: 1266623
• Product Code: FOZ
• UDI-Device Identifier: 00801741110665
• UDI-Public: (01)00801741110665(17)180228(10)REBQ0171
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

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 Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: F218101
• Device Lot Number: REBQ0171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1