MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5FR DL POWERMIDLINE MAX KIT W/GUARDIVA; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	P4255108DG
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 rebw0645 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that during the procedure the healthcare professional was unable to thread the catheter as it appeared to be occluded.The procedure was stopped, device removed and a new kit was opened to complete the procedure.No harm to the patient.
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 that the catheter could not be threaded over the guidewire was confirmed and the cause was determined to be supplier related.One 5fr d/l powermidline and one guidewire were returned for investigation.A functional test revealed that the guidewire would not pass through the lumen with the red connector.Material from the molding process was obstructing a portion of the lumen with the red connector.The sample was forwarded to the manufacturing facility for further review.Reynosa evaluation: the complaint for ¿catheter appeared to be occluded¿ is confirmed as supplier related.According to the microscopic evaluation an occlusion caused by silicon was found in the molded bifurcation area.A lot history review (lhr) of rebw0645 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that during the procedure the healthcare professional was unable to thread the catheter as it appeared to be occluded.The procedure was stopped, device removed and a new kit was opened to complete the procedure.No harm to the patient.

• Brand Name: 5FR DL POWERMIDLINE MAX KIT W/GUARDIVA
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7170222
• Report Number: 3006260740-2018-00002
• Device Sequence Number: 1173682
• Product Code: PND
• UDI-Device Identifier: 00801741129384
• UDI-Public: (01)00801741129384
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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 Catalogue Number: P4255108DG
• Device Lot Number: REBW0645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1