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 Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer "during our midline procedures we use a product which contains the needle as well as guide wire in one.Easily accessed right basilic vein and walked needle in a few centimeters before advancing guide wire then advancing catheter.Felt some resistance while advancing catheter from needle, used ultrasound to find needle tip and found it was through vessel wall and down by 1-2cm.Held onto prongs of midline catheter and retracted rest of midline product, as i was unable to retract guidewire back into midline product.Catheter with wings and hub of catheter intact.Wing part of product removed only to find that needle still attached inside catheter with about 1-2cm of end of needle exposed.Needle needed to be physically removed from the catheter." additional info 07/30/2024: it was reported by the customer patient¿s vessel was double walled, this is vessel injury and predisposes the patient to complication.The catheter was successfully placed.No injury reported.
Event or Problem Description
It was reported by the customer "during our midline procedures we use a product which contains the needle as well as guide wire in one.Easily accessed right basilic vein and walked needle in a few centimeters before advancing guide wire then advancing catheter.Felt some resistance while advancing catheter from needle, used ultrasound to find needle tip and found it was through vessel wall and down by 1-2cm.Held onto prongs of midline catheter and retracted rest of midline product, as i was unable to retract guidewire back into midline product.Catheter with wings and hub of catheter intact.Wing part of product removed only to find that needle still attached inside catheter with about 1-2cm of end of needle exposed.Needle needed to be physically removed from the catheter." additional info 07/30/2024: it was reported by the customer patient¿s vessel was double walled, this is vessel injury and predisposes the patient to complication.The catheter was successfully placed.No injury reported.
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 detached needle is confirmed and was determined to be related to manufacturing.The product returned for evaluation was one 18g powerglide pro device.A gross visual inspection of the returned unit found that the needle was detached from the needle housing and was returned separately inside a bd vacutainer device.Microscopic inspection of the needle found scratch marks on the proximal end of the needle, indicating that the needle had come into contact with a hard surface.Further inspection found that no adhesive residue was present on the needle.Inspection of the needle housing under a uv light found small traces of adhesive on the distal end of the housing.However, no adhesive was observed inside the needle housing.The quantity of adhesive observed indicated that insufficient adhesive had been applied, creating a poor bond between the two components.The investigation was forwarded to the manufacturing facility for further evaluation.

• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20034062
• Report Number: 3006260740-2024-04586
• Device Sequence Number: 6423830
• Product Code: FOZ
• UDI-Device Identifier: 00801741142659
• UDI-Public: (01)00801741142659(11)240315(17)250930(10)REJN3695
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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): 02/10/2025

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F118100T
• Device Lot Number: REJN3695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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