MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (22G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all 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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that catheter sheared when pulled back onto device after advancing catheter wings.Patient underwent surgery to remove sheared catheter.Additional information received 7/14/2023: customer reports that the break was discovered when scanning the patient's arm.X-ray and ultrasound were used to confirm catheter piece remained in the patient.Patient complained of pain at the site.Another powerglide midline was placed in the other arm, and they had to stop other meds to give the med they needed give.Catheter piece was successfully removed via surgery at bedside.No other information 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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged midline catheter was confirmed.The product returned for evaluation was 22ga x 8cm powerglide pro midline catheter.Usage residues were observed throughout the sample.The catheter terminated approximately 3.5cm from the molded joint.Microscopic inspection of the break surface revealed a partially glossy and partially granular fracture surface.A longitudinally aligned scoring mark was observed on the inside surface of the catheter shaft leading into the fracture site.The fracture features were consistent with damage caused by contact between the catheter shaft and the tip of the introducer needle.Such damage can occur if the catheter is withdrawn onto the needle shaft and if the needle is re-inserted into the catheter following catheter advancement.
Event or Problem Description
It was reported by the customer that catheter sheared when pulled back onto device after advancing catheter wings.Patient underwent surgery to remove sheared catheter.Additional information received 7/14/2023: customer reports that the break was discovered when scanning the patient's arm.X-ray and ultrasound were used to confirm catheter piece remained in the patient.Patient complained of pain at the site.Another powerglide midline was placed in the other arm, and they had to stop other meds to give the med they needed give.Catheter piece was successfully removed via surgery at bedside.No other information provided.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (22G) (8CM)
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17366756
• Report Number: 3006260740-2023-03092
• Device Sequence Number: 7405198
• Product Code: FOZ
• UDI-Device Identifier: 00801741142680
• UDI-Public: (01)00801741142680
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F122080T
• Device Lot Number: REHQ2335
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 79 KG