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

Model Number N/A

Device Problems Break (1069); Material Rupture (1546)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reds0284 showed three other similar product complaint(s) from this lot number.

Event Description

It was reported, "the first chemotherapy after implantation began on (b)(6) 2020 ((b)(6) 2020), and the second chemotherapy after implantation began on (b)(6) 2021 ((b)(6) 2021).During treatment, the patients were discharged from hospital and went home to rest for maintenance every seven days.On (b)(6) 2021, the patient was readmission, catheter maintenance was performed and rupture of the catheter was found.".

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: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken groshong catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs depicting a 4fr s/l groshong nxt catheter.The depicted device was assembled with a two-piece connector.A complete break was observed just distal of the connector.The break site appeared to be irregular.Catheter damage was evident in the provided photographs; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include tensile (pulling) stress and sharp instrument contact.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported, "the first chemotherapy after implantation began on (b)(6) 2020 (b)(6) 2020, and the second chemotherapy after implantation began on (b)(6) 2021 (b)(6) 2021.During treatment, the patients were discharged from hospital and went home to rest for maintenance every seven days.On (b)(6) 2021, the patient was readmission, catheter maintenance was performed and rupture of the catheter was found.".

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
• 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
• MDR Report Key: 11388667
• MDR Text Key: 238862025
• Report Number: 3006260740-2021-00541
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: REDS0284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other