MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT STC PPICC, SOLO, 5FR; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redr3510 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc is kinking on itself under the existing dressing.No other information was provided.
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 of a kink in the catheter was confirmed, but the exact cause could not be determined from the photograph that was provided for investigation.The photograph showed the section of a powerpicc solo between the molded wings and the insertion site.The wings were attached and secured to a statlock stabilization device.The statlock device was adhered to the patient.A fold was observed in the statlock substrate near the bottom corner of the retainer.The 5cm depth mark was positioned at the insertion site.The catheter tubing was kinked between the 2 and 3 cm depth marks and between the 3 and 4 cm depth marks.The position of the catheter and angle of insertion may have been potential contributing factors, but the exact cause could not be determined.The instructions for use state, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ a lot history review (lhr) of redr3510 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc is kinking on itself under the existing dressing.No other information was provided.

• Brand Name: DOT STC PPICC, SOLO, 5FR
• 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: 9539032
• Report Number: 3006260740-2019-04030
• Device Sequence Number: 2426511
• Product Code: LJS
• UDI-Device Identifier: 00801741085727
• UDI-Public: (01)00801741085727
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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 Model Number: N/A
• Device Catalogue Number: 1395118Q
• Device Lot Number: REDR3510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1