MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER 3F RADIOLOGY BASIC TRAY SL W/HYDRO-GLIDE INSERTION STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	3173355
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2023
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported via medwatch "dressing change to be completed per policy.During dressing change, stat lock applied and picc hub completely separated from picc line during securement.Picc had to be removed due to risk for infection and was replaced under sedation.".
Event or Problem Description
It was reported via medwatch "dressing change to be completed per policy.During dressing change, stat lock applied and picc hub completely separated from picc line during securement.Picc had to be removed due to risk for infection and was replaced under sedation." additional information provided 01/02/2024: broke at hub ¿ had been in 1 day, line needed to be replaced.Additional information received 01/04/2024: to my knowledge patient did not have retained fragments or imaging.
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.
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 catheter break is confirmed, but the root cause could not be determined.One photo of a 3fr powerpicc sv catheter was returned for evaluation.Review of the photo found that the catheter tubing was separated or broken off from the molded joint before the 0cm depth marker.The photo did not provide enough detail to comment on the nature of the break.Based on the available material for review, the complaint is confirmed but there is insufficient evidence to identify the root cause.
Event or Problem Description
It was reported via medwatch "dressing change to be completed per policy.During dressing change, stat lock applied and picc hub completely separated from picc line during securement.Picc had to be removed due to risk for infection and was replaced under sedation." additional information provided 01/02/2024: broke at hub ¿ had been in 1 day, line needed to be replaced additional information received 01/04/2024: to my knowledge patient did not have retained fragments or imaging.

• Brand Name: POWERPICC SV CATHETER 3F RADIOLOGY BASIC TRAY SL W/HYDRO-GLIDE INSERTION STYLET
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18014111
• Report Number: 3006260740-2023-04877
• Device Sequence Number: 7469637
• Product Code: LJS
• UDI-Device Identifier: 00801741027567
• UDI-Public: (01)00801741027567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2024

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 Catalogue Number: 3173355
• Device Lot Number: REHQ1780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 01/08/2024; 02/01/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/10/2024; 02/22/2024
• 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: 11 YR
• Patient Sex: Female
• Patient Weight: 21 KG
• Patient Race: White