MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that "blood return noted on flow sheets for multiple days.No tpa administrations or power injections noted in chart.Patient required no additional treatment or intervention once line removed.Upon removal, tear in external portion of the line between 35-40cm markings.The tear seems to be 5cm long.".
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 complaint of a split in the catheter is confirmed, but a root cause could not be established.One 4 fr s/l powerpicc was returned for evaluation.An initial visual observation showed blood use residues, and a needleless injection cap and a statlock stabilization device was returned attached to the device.A large tear in the catheter was observed just proximal to the 34 cm depth marker that runs just distal of the 38 cm depth marker.The split was longitudinally aligned and approximately 4 cm long.A microscopic observation revealed the fracture site to be along an extrusion feature, and the fracture surface appeared smooth without an identifiable initiation point.The wall thickness was measured where the extrusion feature was identified and was within drawing specifications.Based on the state of the large split, a cause could not be identified for the initiation of the split.Possible causes of this failure may be sharp instrument damage during removal, interactions with biological features within the dynamic vasculature of the patient, or other unidentified causes.The complaint of a catheter split is confirmed; however, an exact cause could not be determined due to the nature of the complaint.
Event or Problem Description
It was reported by the customer that "blood return noted on flow sheets for multiple days.No tpa administrations or power injections noted in chart.Patient required no additional treatment or intervention once line removed.Upon removal, tear in external portion of the line between 35-40cm markings.The tear seems to be 5cm long.".

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F
• 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: 16542239
• Report Number: 3006260740-2023-00829
• Device Sequence Number: 6388982
• Product Code: LJS
• UDI-Device Identifier: 00801741035555
• UDI-Public: (01)00801741035555
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 9174108D
• Device Lot Number: REGR2644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 70 KG