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

Model Number N/A

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, radiographic image analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of low visibility of the catheter was confirmed but the cause is unknown.A single front chest radiograph was returned for evaluation of this complaint.There was a left sided central line that was seen up until the mediastinum where the quality of the image reproduction prevented evaluation for the tip.The catheter appeared to be in the correct position, but the original image would need to be windowed and leveled to be sure.The exact cause of the low visibility of the catheter could not be determined but may have been affected by multiple factors including the image reproduction, the radiopacity of the catheter, patient build, machine setting, the technique of image acquisition, rotation of the patient, and overlapping structures.A lot history review (lhr) of refp4091 showed nine other similar product complaint(s) from this lot number.

Event Description

It was reported that the position of the catheter tip was not visualized.The puncture operator was unsatisfied since it needed to go back and forth to the radiography department.On (b)(6) 2022 - the returned sample exhibited low visibility of the catheter.

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CVC
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15699903
• MDR Text Key: 306884346
• Report Number: 3006260740-2022-04201
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871080
• 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
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: REFP4091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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): Other