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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer they had a leak with a 5 fr picc line.Additional information received 7/9/2024: it was reported by the customer "during the installation of the catheter, we noticed the presence of several leaks on it which causes fluid leakage during injection in several places on the catheter shaft rather than only at the end of the catheter on the orifice of it.This means that when injecting a drug, the full dose is not delivered at the end of the catheter as normal therefore we have to replace the catheter with another catheter.".
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 leak was confirmed.The product returned for evaluation was one 5fr dl groshong nxt catheter.The catheter tubing was returned in two segments.Inspection of the break site found striation markings, indicating that the tubing had likely been intentionally cut.The catheter was leak tested by flushing each lumen with water using a 12ml luer lok syringe.During testing, a leak was observed between the 38 cm and 39 cm depth markers.Microscopic inspection of the leak site found that four diagonal tears were present.Three of these tears were s-shaped and penetrated the catheter wall.The fourth tear did not penetrate the catheter wall, indicating that the damage likely originated from an external source.Inspection of the fractures found that that the edges were sharp and well defined.The fracture surfaces had catheter material that was sheared.Based on the observed features, it is possible that damage caused by a blunt instrument contributed to the observed failure.However, there is not sufficient evidence to conclusively determine this.Therefore, the root cause remains unknown.
Event or Problem Description
It was reported by the customer they had a leak with a 5 fr picc line.Additional information received on 7/9/2024: it was reported by the customer "during the installation of the catheter, we noticed the presence of several leaks on it which causes fluid leakage during injection in several places on the catheter shaft rather than only at the end of the catheter on the orifice of it.This means that when injecting a drug, the full dose is not delivered at the end of the catheter as normal therefore we have to replace the catheter with another catheter.".

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19734911
• Report Number: 3006260740-2024-03683
• Device Sequence Number: 8122731
• Product Code: LJS
• UDI-Device Identifier: 00801741035388
• UDI-Public: (01)00801741035388(11)230923(17)250731(10)REHV1406
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/23/2025

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 Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 7857505
• Device Lot Number: REHV1406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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