MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE MIDLINE CATHETER 20G, 10CM FULL INSERTION KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the midline catheter separated while the nurse was placing the midline.Additional information june 24: it was reported the negative outcome was that the patient had to have the line pulled and replaced.
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported that the midline catheter separated while the nurse was placing the midline.Additional information june 24: it was reported the negative outcome was that the patient had to have the line pulled and replaced.
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 detached catheter is inconclusive due to the state of the returned sample.Three photographs of a powerglide pro were returned for evaluation.An initial visual observation of the photographs showed the catheter of the powerglide pro was separated from the wings/carrier of the device.Evidence of use was observed within the catheter, and the catheter tubing was observed to be curved in multiple locations.No breaks, splits, or cracks could be seen on the returned sample.Inspection of the returned photographs were insufficient to identify the alleged issue or a root cause of the reported issue.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.
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 separated catheter could not be confirmed.The product returned for evaluation was one 20 g powerglide pro catheter.Gross visual inspection of the returned unit found that the safety mechanism was engaged over the needle tip.Use residue was observed throughout the unit.The needle and catheter were bent at a similar angle.However, in the photos the needle is straight and the catheter tubing is bent in an s-shape, suggesting that the needle was bent after the reported event.Microscopic inspection did not identify any damage to the components.The guidewire was advanced to inspect for damage.The guidewire advanced without resistance and no damage was observed.The catheter assembly was coupled with the wings to inspect the fit between the two components.The two components coupled adequately.Based on the available evidence, the customer's reported defect could not be confirmed.Along with the powerglide device, a nexiva safety mechanism was returned, but visual inspection did not find any damage to the device.
Event or Problem Description
It was reported that the midline catheter separated while the nurse was placing the midline.Additional information on june 24: it was reported the negative outcome was that the patient had to have the line pulled and replaced.

• Brand Name: POWERGLIDE MIDLINE CATHETER 20G, 10CM FULL INSERTION KIT
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19704982
• Report Number: 3006260740-2024-03586
• Device Sequence Number: 3653925
• Product Code: FOZ
• UDI-Device Identifier: 00801741075308
• UDI-Public: (01)00801741075308
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• 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,Followup
• Report Date (Section B): 10/22/2024

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 Model Number: N/A
• Device Catalogue Number: M020101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/31/2024; 10/22/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/04/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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