MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F; 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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 redx4201 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that powerpicc solo catheter developed mechanical occlusions(kinking) in-situ after insertion.The insertion was unremarkable with no difficulties, flushed and aspirated without resistance on insertion but patient developed occlusion.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a twisted catheter is confirmed but the exact cause remains unknown.One radiographic image of a catheter within a patient was provided for evaluation.The catheter appears to be inserted in the left arm.The catheter shaft and a two-pronged securement device are visible.The catheter tubing distal to the securement location appears to create a loop and a kink at the apex of the loop.The condition of the catheter could not be clearly inspected due to the lack of a physical sample.Based on the description of the reported event and image provided, possible contributing factors include placement location, securement method, and movement of the catheter within the patient leading to kinking.Since the radiographic image appears show two kinks in the tubing, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that powerpicc solo catheter developed mechanical occlusions(kinking) in-situ after insertion.The insertion was unremarkable with no difficulties, flushed and aspirated without resistance on insertion but patient developed occlusion.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F
• 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: 11607451
• Report Number: 3006260740-2021-01089
• Device Sequence Number: 11736872
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 1295118
• Device Lot Number: REDX4201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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