MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 2F BASIC TRAY SINGLE-LUMEN 30 CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Failure to Infuse (2340); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx2308 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2308) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported white cannula possibly causes a "bend" in this catheter, causing resistance, which impairs the flow of the infusion.It was started it may be causing obstruction.No other information was provided.
Event or Problem Description
It was reported white cannula possibly causes a "bend" in this catheter, causing resistance, which impairs the flow of the infusion.It was started it may be causing obstruction.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 catheter kink is confirmed but the exact cause remains unknown.Three photos of a 2 fr perqcath catheter were provided for evaluation.The first image shows the catheter inserted within a patient¿s neck region.A slight bend in the catheter is noted at the proximal region extending past the over-sleeve the second and third photos are of the kit tray packaging.The product label information indicates lot: redx2308.Since a kink in the catheter appeared to be present and may have affected the infusion patency, the complaint is confirmed but the exact cause remains unknown.Based on the information provided, possible contributing factors include placement location and securement method.
Event or Problem Description
It was reported white cannula possibly causes a "bend" in this catheter, causing resistance, which impairs the flow of the infusion.It was started it may be causing obstruction.No other information was provided.Additional information: due to loss of the catheter due to obstruction, a new procedure had to be performed, being another invasive process for the patient, with risk of infection.After obstruction of the catheter in a patient with difficult venous access, a procedure called phlebotomy had to be performed.Every picc pass involves x-ray and the use of contrast to visualize its location.Parenteral nutrition, vasoactive drugs, antibiotics, sedation, etc.Were being administered to this catheter.

• Brand Name: PER-Q-CATH PLUS PICC 2F BASIC TRAY SINGLE-LUMEN 30 CM
• 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: 12527571
• Report Number: 3006260740-2021-03981
• Device Sequence Number: 17258199
• Product Code: LJS
• UDI-Device Identifier: 00801741074820
• UDI-Public: (01)00801741074820
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2021

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: 4132005
• Device Lot Number: REDX2308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/08/2021; 10/18/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/14/2021; 10/26/2021
• 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