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

Catalog Number	F120101
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 reas2455 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the nurse that while placing a midline and getting the tip in the vein, she was able to get blood return.She then advanced the wire without incident.The catheter was then deployed but would not fully advance.The nurse tried pulling back the wire but it became stuck.She gently worked the catheter out and stated that toward the end she felt like it snapped.The wire came out bent and was broken off the main shaft of the wire.The contact (nurse) had another picc nurse verify that the tip was intact and all wires measured exactly when compared to another powerglide catheter.No hematoma or continued bleeding at the insertion site was noted.
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 break in the wire was confirmed and the cause appears to be use related.The product returned for evaluation was a 20ga x 10cm powerglide pro.Gross visual evaluation of the implicated device revealed that the guidewire was broken and an elongated segment of wire protruded from the needle.A separated wire segment did not have elongation of the wire coil and contained a kink in the wire.Further evaluation of the catheter revealed a small split in the tubing near the distal catheter end.Microscopic examination of the detached wire segment showed that the fracture edges of the wire were sharply formed and contained material flow similar to shearing damage.Microscopic examination of the catheter fracture surfaces revealed jagged and sharply formed edges.The observed catheter damage was characteristic of a secondary advancement of the catheter which resulted in the needle having punctured through the catheter.It is possible that the guidewire damage was also associated with this event as puncturing the catheter with the wire still advanced would have resulted in a potential kink of the wire, damage to the catheter, and could have resulted in difficulty withdrawing the wire due to contact with the catheter and possibly the needle bevel.The product ifu provides the following precautions: ¿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.¿ ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.¿.
Event or Problem Description
It was reported by the nurse that while placing a midline and getting the tip in the vein, she was able to get blood return.She then advanced the wire without incident.The catheter was then deployed but would not fully advance.The nurse tried pulling back the wire but it became stuck.She gently worked the catheter out and stated that toward the end she felt like it snapped.The wire came out bent and was broken off the main shaft of the wire.The contact (nurse) had another picc nurse verify that the tip was intact and all wires measured exactly when compared to another powerglide catheter.No hematoma or continued bleeding at the insertion site was noted.

• Brand Name: DOT PFLEX, 20G 10CM FULL (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: 6365533
• Report Number: 3006260740-2017-00158
• Device Sequence Number: 925527
• Product Code: FOZ
• UDI-Device Identifier: 00801741110580
• UDI-Public: (01)00801741110580(17)171128(10)REAS2455
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

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: 11/28/2017
• Device Catalogue Number: F120101
• Device Lot Number: REAS2455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1