MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "on (b)(6) 2024 a patient came to the er for picc assessment.The picc line was placed on (b)(6) 2024 and was left exposed at 0 cm.The patient stated that he had noticed swelling under the skin near the insertion site when flushing.The home health rn decided to pull the catheter out 3 cm and then noticed the crack.He arrived in the er, and at that time i removed the picc line.When i attempted to flush the catheter post removal, a blood clot was dislodged from the tip of the catheter measuring around an inch.The patient also stated to me that his line had become difficult to flush ¿ but stated that he did not think he applied excessive pressure while attempting to flush." no other information was provided.
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 device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.H3 other text : device not received.
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.
Event or Problem Description
It was reported, "on (b)(6) 2024 a patient came to the er for picc assessment.The picc line was placed on (b)(6) 2024 and was left exposed at 0 cm.The patient stated that he had noticed swelling under the skin near the insertion site when flushing.The home health rn decided to pull the catheter out 3 cm and then noticed the crack.He arrived in the er, and at that time i removed the picc line.When i attempted to flush the catheter post removal, a blood clot was dislodged from the tip of the catheter measuring around an inch.The patient also stated to me that his line had become difficult to flush ¿ but stated that he did not think he applied excessive pressure while attempting to flush." no other information was provided.
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.
Event or Problem Description
It was reported, "on (b)(6) 2024 a patient came to the er for picc assessment.The picc line was placed on (b)(6) 2024 and was left exposed at 0 cm.The patient stated that he had noticed swelling under the skin near the insertion site when flushing.The home health rn decided to pull the catheter out 3 cm and then noticed the crack.He arrived in the er, and at that time i removed the picc line.When i attempted to flush the catheter post removal, a blood clot was dislodged from the tip of the catheter measuring around an inch.The patient also stated to me that his line had become difficult to flush ¿ but stated that he did not think he applied excessive pressure while attempting to flush." no other information was provided.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19239835
• Report Number: 3006260740-2024-02105
• Device Sequence Number: 15435704
• Product Code: LJS
• UDI-Device Identifier: 00801741141133
• UDI-Public: (01)00801741141133(11)240220(17)250531(10)REHZ1652
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000757
• Device Lot Number: REHZ1652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 09/17/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/03/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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