MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (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 Code	Foreign Body In Patient (2687)
Date of Event	08/23/2024
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 complaint of a break in the catheter was confirmed.The product returned for evaluation was one 20 ga powerglide pro.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument, likely the integrated needle.The returned product sample was evaluated and a break in the catheter was observed approximately halfway down the catheter shaft.Microscopic examination of the catheter hole confirmed it was typical of contact with a needle, and the characteristics observed which supported this type of failure included: ¿ the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on the bevel of a needle.¿ the fracture edges were sharply formed and had planar (flat) surfaces.¿ the damage also contained the overall shape of a chevron 'v'.This shape is common to many needle bevels, and this shape is often transferred onto the catheter when punctured by a needle.Pulling the catheter back along the needle shaft during attempted insertion may cause a split in the catheter from the needle bevel.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that powerglide was placed on a patient, had some difficulty threading and when she dc'd the device, part of the catheter broke off in the patient.The placer was able to retrieve the broken piece without further intervention.Additional information 08/28/2024: upon meeting resistance, pulling back and the catheter was not intact so they had to retrieve the broken piece.The patient went through an additional stick and had to have the catheter piece retrieved at the bedside.No pieces remain in the patient, all were accounted for.There is no imaging available for this incident.No securement devices were used as this took place during placement.
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that powerglide was placed on a patient., had some difficulty threading and when she dc'd the device, part of the catheter broke off in the patient.The placer was able to retrieve the broken piece without further intervention.Additional information 08/28/2024: upon meeting resistance, pulling back and the catheter was not intact so they had to retrieve the broken piece.The patient went through an additional stick and had to have the catheter piece retrieved at the bedside.No pieces remain in the patient, all were accounted for.There is no imaging available for this incident.No securement devices were used as this took place during placement.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20256574
• Report Number: 3006260740-2024-05296
• Device Sequence Number: 15450557
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666(11)240613(17)251231(10)REJS1154
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/22/2024

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 Expiration Date: 12/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F120080T
• Device Lot Number: REJS1154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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