MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
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 by customer that a sl picc line on an inpatient today, and the peel away sheath broke at the hub and literally vacuumed into the patient's vein.It took the radiologist awhile and difficulties to try to snare this out of the patient's vein.
Event or Problem Description
It was reported by customer that a sl picc line on an inpatient today, and the peel away sheath broke at the hub and literally vacuumed into the patient's vein.It took the radiologist awhile and difficulties to try to snare this out of the patient's vein.
Additional Manufacturer Narrative
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 complaint of introducer sheath damage was confirmed; however, the root cause was not identified.The product returned for evaluation was one 4.5fr peel-apart sheath.The sample was received without the vessel dilator.Blood residue was observed on the sample.The sample was received in two segments which shared a complete break just distal of the orange finger tabs.Microscopic inspection of the break site revealed a granular fracture surface with regions of increased luster.Plastic deformation and mechanical damage were observed at the fracture site.Multiple parallel impressions were observed in the vicinity of the break.Matching tool impressions were also observed along the distal surface of the orange finger tabs.An attempt to peel the orange finger tabs was successful and unremarkable.An attempt to replicate the sample fracture using a non-complainant device was unsuccessful, as the grey ptfe sheath separated from the orange finger tabs prior to material failure.The abundant mechanical damage suggested that manipulation of the sample using a traumatic instrument likely contributed to the observed break; however, attempts to replicate the damage through such manipulation were unsuccessful, suggesting that an additional, unidentified factor(s) also contributed.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17819731
• Report Number: 3006260740-2023-04312
• Device Sequence Number: 16719838
• Product Code: LJS
• UDI-Device Identifier: 00801741027772
• UDI-Public: (01)00801741027772
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• 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
• Report Date (Section B): 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3194335
• Device Lot Number: REHN1743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: Required Intervention
• Patient Sex: Unknown