MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET (4F) (SINGLE-LUMEN); 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	09/08/2023
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that the picc line actually knot while being inserted.No other information was provided.Additional information received 08 october 2023: picc was not kinked or bent prior to insertion into vein.Urgent due to being unable to remove knotted picc line.Picc line knotted in patient arm which required interventional radiology to remove.Did not interrupt the administration of any medication as patient had other iv access.
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.Based on a review of this information, the following was concluded: the complaint of a knotted catheter is confirmed; however, the root cause could not be determined.One radiographic image of a catheter was returned for evaluation.An initial visual observation of the radiographic image showed an implanted catheter that appears to be knotted.It appears the stylet was within the catheter and terminated at the location of the knot.Although it appeared the catheter was knotted in the submitted radiographic image, inspection of the radiographic image was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that the picc line actually knot while being inserted.No other information was provided.Additional information received 08 october 2023: picc was not kinked or bent prior to insertion into vein.Urgent due to being unable to remove knotted picc line.Picc line knotted in patient arm which required interventional radiology to remove.Did not interrupt the administration of any medication as patient had other iv access.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET (4F) (SINGLE-LUMEN)
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17896047
• Report Number: 3006260740-2023-04581
• Device Sequence Number: 16985717
• Product Code: LJS
• UDI-Device Identifier: 00801741131790
• UDI-Public: (01)00801741131790
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000677
• Device Lot Number: REHQ1762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: White