MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SINGLE-LUMEN PICC (60CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440)

Event Date 12/09/2023

Event Type  Injury  

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.

Event Description

It was reported, "on (b)(6) 2023, the patient underwent picc indwelling catheterization, and the operation went smoothly.At 4 p.M., the patient complained of pain in the upper arm when bending the arm, and was given to improve the upper limb blood vessels, and the b-ultrasound examination showed that venous thrombosis had formed, anticoagulant therapy was given, the pain subsided, and the picc straw was electively withdrawn." no other information was provided.

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC (60CM)
• Type of Device: 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: 18603507
• MDR Text Key: 334026101
• Report Number: 3006260740-2024-00220
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035326
• UDI-Public: (01)00801741035326
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7717405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention