MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that customer placed a midline in a patient using an ast powerglide.Upon the catheter launching from the needle customer noticed immediately that the needle safety did not deploy.Therefore, customer had an unprotected and exposed needle after performing the procedure.Customer placed the unit in an empty sharps container immediately following the procedure.
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 device has not been received by the manufacturer for evaluation.
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.Based on a review of this information, the following was concluded: the complaint of the safety mechanism did not engage is confirmed and was determined to be manufacturing related.One 18 ga powerglide pro was returned for evaluation.An initial visual observation showed use residues throughout the returned powerglide pro device.The catheter was observed to be missing from the device.The guidewire was observed to be completely advanced.While the catheter had been advanced, the safety mechanism remained at the base of the needle, leaving the needle tip exposed.A functional test of disassembling the powerglide pro to view the needle safety mechanism revealed slight resistance when attempting to slide the safety down the needle shaft.The safety advanced and the needle shaft was subsequently observed under the microscope.A microscopic observation revealed excessive adhesive along the needle shaft where the needle safety mechanism sits before use of the device.A uv light revealed excessive adhesive along the needle shaft.Because excessive adhesive was found along the needle shaft, the complaint of the needle safety did not advance is confirmed and was determined to be related to manufacturing due to misapplied adhesive.This complaint will be recorded for future trending and monitoring purposes.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.
Event or Problem Description
It was reported by customer that customer placed a midline in a patient using an ast powerglide.Upon the catheter launching from the needle customer noticed immediately that the needle safety did not deploy.Therefore, customer had an unprotected and exposed needle after performing the procedure.Customer placed the unit in an empty sharps container immediately following the procedure.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: 17769542
• Report Number: 3006260740-2023-04169
• Device Sequence Number: 7165690
• Product Code: FOZ
• UDI-Device Identifier: 00801741142703
• UDI-Public: (01)00801741142703
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F118101T
• Device Lot Number: REGZ1823
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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