MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE ST MIDLINE CATHETER FULL KIT (20G) (8CM)

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	06/25/2024
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by customer that the powerglide st kinking directly after insertion, line won't aspirate, removed catheter and visible catheter kinking.No other information was provided.
Event or Problem Description
It was reported by customer that the powerglide st kinking directly after insertion, line won't aspirate, removed catheter and visible catheter kinking.No other information was provided.
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 kinked catheter could not be confirmed.The products returned for evaluation were four sealed 20g powerglide st catheter kits.Additionally, a loose introducer needle and statlock pouch were returned.Each kit was opened and the components inspected.Gross visual inspection did not identify any damage to the components and no kinking was observed.Each kit was then tested by simulating the insertion procedure against mock skin following the kit's instructions for use.No kinking was observed on any of the catheters during or after testing.Each catheter was tested for occlusions by flushing with water using a 12 ml luer lock syringe.No occlusions were identified in any of the units.Based on the available evidence, the returned product appears to have functioned as intended and the reported event could not be reproduced.Therefore, the customer's reported defect could not be confirmed.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER FULL KIT (20G) (8CM)
• Common Device Name: MIDLINE CATHETER
• 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: 19807144
• Report Number: 3006260740-2024-03942
• Device Sequence Number: 7394952
• Product Code: PND
• UDI-Device Identifier: 00801741139314
• UDI-Public: (01)00801741139314(11)240215(17)250531(10)REHZ1381
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170158
• 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): 11/08/2024

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 Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: ST220081
• Device Lot Number: REHZ1381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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