MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH MICROINTRODUCER; 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	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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 after placement of the groshong catheter, the dual lumen junction was ruptured.It was mentioned that the statlock was fixed in the wrong position and that external pressure may have been the cause of the tear.We are pulling up the product to confirm that there was no product-related problem, just to be sure.There was no reported patient injury.Additional information 03/08/2024: it was reported, "the complete break has caused a rupture.".
Event or Problem Description
It was reported that after placement of the groshong catheter, the dual lumen junction was ruptured.It was mentioned that the statlock was fixed in the wrong position and that external pressure may have been the cause of the tear.We are pulling up the product to confirm that there was no product-related problem, just to be sure.There was no reported patient injury.Additional information 03/08/2024: it was reported, "the complete break has caused a rupture.".
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 complaint of a break is confirmed and was determined to be use related.The product returned for evaluation was a 5fr double lumen groshong nxt catheter and a statlock device with the suture wings.The catheter was terminated proximal to the 56cm depth marking.Part of the catheter shaft could be seen within the molded joint of the extension set.Use residue was observed on the statlock.The catheter was lightly stretched which revealed material necking 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, material necking, 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.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH MICROINTRODUCER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19004472
• Report Number: 3006260740-2024-01367
• Device Sequence Number: 12873216
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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