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	07/09/2020
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 reeq2428 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reeq2428) have been reported from the same facility.
Event or Problem Description
It was reported the picc was inserted 7/3, 7/9 pulled back 1-2cm, then replaced 7/12 for ij malposition.
Event or Problem Description
It was reported the picc was inserted 7/3, 7/9 pulled back 1-2cm, then replaced 7/12 for ij malposition.
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 malposition is inconclusive due to poor sample condition.One x-ray image was provided for evaluation.The upper arm and torso region is shown in the image.Multiple lines are visible in lower chest area.A catheter appears to be present on the right arm of the patient.The image was forwarded to a radiologist consultant for further review.The consultant review found the a right internal jugular cvc catheter to have its tip over the cavoatrial junction and a right sides picc to have its tip over the superior vena cava in the location of the 2 cm blue line.The position of the picc tip during initial placement is unknown.Based on the description of the reported event, possible contributing factors include placement location, securement method, and catheter manipulation during use.Since the initial location of the catheter and handling methods are unknown, the complaint remains inconclusive at this time.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.

• 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: 10677128
• Report Number: 3006260740-2020-20096
• Device Sequence Number: 17008425
• 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): 11/26/2020

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: S1395108D3
• Device Lot Number: REEQ2428
• 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: 11/26/2020
• 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: 81 YR