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

Model Number 7717405

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

Patient Problem Thrombosis (2100)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recw0194 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the patient underwent a peripheral central venous catheterization in our hospital on (b)(6) 2020, and started on (b)(6) with low molecular weight heparin 5000 iu, qd ¿¿subcutaneous injection for 4 days.On (b)(6), the patient developed pain during the walking of the picc tube of the right upper extremity.The color doppler ultrasound examination showed thrombosis in the wall of the indwelling tube.The symptoms improved after anticoagulation treatment.

• Brand Name: GROSHONG 4F SL PICC (60 CM)
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10788127
• MDR Text Key: 214653902
• Report Number: 3006260740-2020-20382
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 7717405
• Device Catalogue Number: 7717405
• Device Lot Number: RECW0194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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): Other