MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F TL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bd 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 bd.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redt4711 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "during picc insertion, vessel was accessed with steel needle, introducer wire was deployed and advanced approximately 10cm.Upon failure to advance further, the inserting nurse attempted to remove the steel needle along with the introducer wire simultaneously.The introducer wire would not come out, so the steel needle was removed and the wire could not be removed.Vascular surgery was consulted and the wire was successfully removed by the surgeon by applying increased traction on the wire.The wire is intact but the tip is bent at a 90 degree angle.".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the guidewire was tied in a knot was confirmed and it appeared that the guidewire was damaged during use.One 0.018¿ x 50cm guidewire was received in its hoop.The tip straightener was not returned with the hoop.A knot was observed in the coiled segment of the guidewire 1.5mm from the distal weld tip.A microscopic examination revealed a red colored biological residue within the knotted section of the guidewire.A tactual investigation revealed that the weld tip was intact.Due to the evidence of use on the guidewire, it appeared that the wire inadvertently folded over itself and was twisted into a knot during the procedure.It was reported that the guidewire was inserted through the needle, but could not be removed after the wire could not be advanced.Had the knot existed prior to use, the wire would not have fit through the needle.No manufacturing related defects were noted on the complaint sample.A lot history review (lhr) of redt4711 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "during picc insertion, vessel was accessed with steel needle, introducer wire was deployed and advanced approximately 10cm.Upon failure to advance further, the inserting nurse attempted to remove the steel needle along with the introducer wire simultaneously.The introducer wire would not come out, so the steel needle was removed and the wire could not be removed.Vascular surgery was consulted and the wire was successfully removed by the surgeon by applying increased traction on the wire.The wire is intact but the tip is bent at a 90 degree angle.".

• Brand Name: POWERPICC PROVENA SOLO 5F TL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9769904
• Report Number: 3006260740-2020-00680
• Device Sequence Number: 2495643
• Product Code: LJS
• UDI-Device Identifier: 00801741188831
• UDI-Public: (01)00801741188831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000886
• Device Lot Number: REDT4711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1