MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH SAFETY INTRODUCER; 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 Erythema (1840); Phlebitis (2004); Swelling/ Edema (4577)

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs1536 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported at 8:00 on (b)(6) 2022, it was found that the vein of the picc catheter was in a cord-like shape and induration.The patient had had this symptom before, and it was relieved after active treatment.Now it reappeared, and the patient did not have fever or chills.Symptoms such as redness and swelling rule out the possibility of phlebitis caused by infection.Diagnosis of mechanical phlebitis, suspected catheter foreign body irritation.Phlebitis led to repeated use of topical drugs and skin damage in patient.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH SAFETY INTRODUCER
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15629376
• MDR Text Key: 301975994
• Report Number: 3006260740-2022-04049
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741087035
• UDI-Public: (01)00801741087035
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K926331
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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: 7717305
• Device Lot Number: REFS1536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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