MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Additional 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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported that catheter inserted into right upper arm on april 10.The area around the puncture site was clamped with a suture wing and secured with statlock.All of the catheter part (blue) that was outwardly exposed was pasted and fixed with a dressing to cover it.On (b)(6), the catheter was found to be broken.There was no reported patient injury.
Additional 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 product returned for evaluation was a 5fr dual lumen groshong nxt clearvue catheter with a statlock retaining device.Use residue was observed on the statlock.A break in the catheter shaft was observed within the molded joint, proximal to the 56cm depth marking.The catheter was lightly stretched and exhibited tensile weakness in the vicinity of the break.Microscopic inspection of the break surface on the catheter shaft revealed a granular, uneven surface.The features of the break surface and the location of the break suggests the catheter likely broke due to tensile stress.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that catheter inserted into right upper arm on (b)(6).The area around the puncture site was clamped with a suture wing and secured with statlock.All of the catheter part (blue) that was outwardly exposed was pasted and fixed with a dressing to cover it.On (b)(6), the catheter was found to be broken.There was no reported patient injury.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY
• Common Device Name: 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: 19281027
• Report Number: 3006260740-2024-02267
• Device Sequence Number: 12679893
• Product Code: LJS
• UDI-Device Identifier: 00801741035449
• UDI-Public: (01)00801741035449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7957505
• Device Lot Number: REHU1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown