MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY

Model 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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of inability to advance the guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.The sample was received assembled with the catheter overlaying the needle shaft.Blood residue was observed within the catheter.A diagonally aligned split was observed in the catheter tubing near the distal tip.The catheter appeared deformed in the vicinity of the split.Microscopic inspection of the catheter split revealed sharply defined fracture features.Catheter bunching was observed in the vicinity of the split.Attempts to advance the guidewire were unsuccessful.Following removal of the catheter from the needle, microscopic inspection of the needle notch revealed it to be fully occluded by blood products.Microscopic inspection of the needle bevel revealed a region of increased luster along the distal interior edge.The catheter damage was consistent with retraction of the catheter against the needle bevel.The inability to advance the guidewire was caused by blood product occlusion of the needle shaft.It appeared that during attempted placement, both the guidewire and needle were retracted.The needle shaft became occluded by blood products during that attempt, which prevented subsequent guidewire advancement.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 rebt2034 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebt2034) have been reported from two facilities.
Event or Problem Description
It was reported that the guidewire was missing.No patient injury reported, only required additional sticks.On 03/26/2018- evaluation found that the needle punctured the catheter.

• Brand Name: DOT PG PRO 20G 10CM FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7444879
• Report Number: 3006260740-2018-00748
• Device Sequence Number: 19323584
• Product Code: FOZ
• UDI-Device Identifier: 00801741110580
• UDI-Public: (01)00801741110580
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 04/19/2018

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: F120101
• Device Catalogue Number: F120101
• Device Lot Number: REBT2034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1