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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported after puncturing the patient, the procedure was canceled due to poor shape of the sheath introducer.The procedure was performed again using the same item in the hospital's inventory and the procedure was completed.No other information was provided.Additional information 09/03/2024: the on-site comment was that "the entire sheath was bent," and judging from the above description of "burrs, tears, and blooms".After inserting the sheath (bent in the main body), the catheter was inserted through the sheath, and the sheath was gradually peeled off (performing action), but halfway through, the bent part of the sheath made it impossible to peel off, and the procedure was interrupted.
Event or Problem Description
It was reported after puncturing the patient, the procedure was canceled due to poor shape of the sheath introducer.The procedure was performed again using the same item in the hospital's inventory and the procedure was completed.No other information was provided.Additional information 09/03/2024: the on-site comment was that "the entire sheath was bent," and judging from the above description of "burrs, tears, and blooms".After inserting the sheath (bent in the main body), the catheter was inserted through the sheath, and the sheath was gradually peeled off (performing action), but halfway through, the bent part of the sheath made it impossible to peel off, and the procedure was interrupted.
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 difficulty peeling the sheath is inconclusive.The product returned for evaluation was one 5.0fr microez microintroducer sheath.A gross visual inspection of the returned sample found that the sheath was partially peeled and a portion of the sheath was compressed near the distal end of the sheath.Further inspection under a microscope was unable to find any deformation around the distal end of the peel site that was not caused by the peeling itself.No bends or kinks were observed.The sample was functionally tested by attempting to peel the sheath and comparing that force against the force needed to peel a similar non-complainant unit.There was no-discernable difference in peel force between the devices and no resistance was encountered when peeling the returned sample past the compressed area.The sample did not exhibit any of the features reported in the event; however, as clinical conditions could not be replicated, the complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20304906
• Report Number: 3006260740-2024-05478
• Device Sequence Number: 7791581
• Product Code: LJS
• UDI-Device Identifier: 00801741035449
• UDI-Public: (01)00801741035449(10)REJN1546
• 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): 03/10/2025

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 7957505J
• Device Lot Number: REJN1546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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