MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2023

Event Type  Injury  

Event Description

It was reported by the customer that the patient was admitted to department of respiratory medicine, pneumonia, due to poor peripheral veins, groshong picc was inserted in the basilic vein of the right upper extremity on february 6, inserted 35cm, exposed 3cm, evaluated before catheterization catheter, preflush and test valve function are normal, no abnormality is found in the support guide wire, there is no resistance when the catheter is delivered in the catheter, it is inserted smoothly, no violent catheter delivery, after the puncture is successful, the support guide wire is withdrawn, and there is no traction adhesion the support guide wire was withdrawn smoothly, but the length of the support guide wire was not observed, and the withdrawal inspection was performed.The blood returned smoothly, and the normal saline flushed the catheter smoothly, and no abnormality was found.The nurse in the ward found that about part of the guide wire was exposed in the patient's abdomen, and informed the doctor.The doctor performed a guide wire foreign body removal operation, and took out a support guide wire of about 37cm.The surface of the guide wire was not twisted and discounted.

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of redw4037 showed no other similar product complaint(s) from this batch number.

Event Description

It was reported by the customer that the patient was admitted to department of respiratory medicine, pneumonia, due to poor peripheral veins, groshong picc was inserted in the basilic vein of the right upper extremity on february 6, inserted 35cm, exposed 3cm, evaluated before catheterization catheter, preflush and test valve function are normal, no abnormality is found in the support guide wire, there is no resistance when the catheter is delivered in the catheter, it is inserted smoothly, no violent catheter delivery, after the puncture is successful, the support guide wire is withdrawn, and there is no traction adhesion the support guide wire was withdrawn smoothly, but the length of the support guide wire was not observed, and the withdrawal inspection was performed.The blood returned smoothly, and the normal saline flushed the catheter smoothly, and no abnormality was found.The nurse in the ward found that about part of the guide wire was exposed in the patient's abdomen, and informed the doctor.The doctor performed a guide wire foreign body removal operation, and took out a support guide wire of about 37cm.The surface of the guide wire was not twisted and discounted.The patient's vital signs were stable.

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 following were reviewed as part of this investigation: sample (if available), patient severity, applicable previous investigation(s), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed.One segment of a stiffening stylet was returned for evaluation.An initial visual observation showed the proximal end of the stylet including the flushing hub was missing.A microscopic observation revealed a break at the proximal end of the returned stylet segment.This break was observed to be at a slight angle, but flat and smooth with distinct edges.Striations were observed on the surface of the break, which was also observed to be lustrous.The observed characteristics of the break in the returned stylet indicate that the stylet was cut by a sharp bladed instrument such as scissors.The reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16457601
• MDR Text Key: 310407162
• Report Number: 3006260740-2023-00575
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REDW4037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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
• Patient Age: 80 YR
• Patient Sex: Male