MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN); 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	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redv2044 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redv2044) have been reported from the same facility.
Event or Problem Description
It was reported that the facility experienced an incident in which the 5 fr provena powerpicc had issues with kinking.Additional info.Rec'd 08/31/2020: "placement info: 5 fr triple lumen provena powerpicc placed in the right upper arm, basilic vein.13 cm external length; securacath in place" "on (b)(6) @ 0800, all 3 lumens occluded, unable to flush or obtain blood return.Vascular access team notified; dressing changed and catheter repositioned." on (b)(6) around noon, recurrent occlusion; vascular access team note indicates, ¿picc had a kink, no blood return¿.Catheter exchanged.".
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, 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 a kinked catheter was confirmed.The product returned for evaluation was one 5fr t/l powerpicc provena catheter.Usage residues were observed throughout the sample and needleless injection caps were attached to all three luers.A securacath stabilization device was received with the sample.Depth marking wear was observed just distal of the molded joint and between the 13cm and 17cm depth markings.Multiple kinks were observed in the vicinity of the worn markings.Microscopic inspection of the sample confirmed the presence of kinks in the catheter shaft.The sample kinked preferentially at the kink impression sites during manual manipulation.The kinks appeared to have occurred near the catheter insertion site.Both the kink locations and the accompanying depth marking wear suggested that catheter securement technique likely contributed.A lot history review (lhr) of redv2044 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redv2044) have been reported from the same facility.
Event or Problem Description
It was reported that the facility experienced an incident in which the 5 fr provena powerpicc had issues with kinking.Additional info.Rec'd 08/31/2020: "placement info: 5 fr triple lumen provena powerpicc placed in the right upper arm, basilic vein.13 cm external length; securacath in place" "on (b)(6) @ 0800, all 3 lumens occluded, unable to flush or obtain blood return.Vascular access team notified; dressing changed and catheter repositioned." on (b)(6) around noon, recurrent occlusion; vascular access team note indicates, ¿picc had a kink, no blood return¿.Catheter exchanged.".

• Brand Name: POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN)
• 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: 10547903
• Report Number: 3006260740-2020-03287
• Device Sequence Number: 3507245
• Product Code: LJS
• UDI-Device Identifier: 00801741028168
• UDI-Public: (01)00801741028168
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3385108Q
• Device Lot Number: REDV2044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 43