MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
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 reer0573 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the picc was inserted (b)(6).It was retracted on (b)(6) when it kinked, picc was removed on (b)(6) when it kinked again.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter kink is confirmed but the exact cause remains unknown.One x-ray image was provided for evaluation.A note stating ¿inserted (b)(6) 2020, retracted (b)(6) 2020, removed (b)(6) 2020 when kinked again¿ was included with the image.The x-ray appears to show the upper right arm and chest region of the patient.A powerpicc catheter appears to be present in the right arm region based on the winged hub shape visible.The catheter extending from the hub appears to be slightly bunched and contain a bent region in the catheter shaft.Additional lines are visible in the lower chest area of the x-ray but do not appear to interact with the catheter.Based on the description of the reported event, possible contributing factors include catheter position, catheter securement, and manipulation of the device.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.The lack of a physical sample did not allow for an inspection of the catheter; however, since a kink appeared to be present in the x-ray image, the complaint is confirmed but the exact cause remains unknown.
Event or Problem Description
It was reported the picc was inserted (b)(6) 2020.It was retracted on (b)(6) 2020.When it kinked, picc was removed on (b)(6) 2020 when it kinked again.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10677300
• Report Number: 3006260740-2020-20101
• Device Sequence Number: 19629540
• Product Code: LJS
• UDI-Device Identifier: 00801741155024
• UDI-Public: (01)00801741155024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S1395108D3
• Device Lot Number: REER0573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR