MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that powerglide pro rt midline catheter was sheared off during an insertion attempt during training.5.5cm of catheter was left within the patient¿s arm.Md notified x-ray performed identified catheter in tissues, not vascular, general surgery consulted for removal.No other information was 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.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
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 a damaged catheter is confirmed; however, the root cause could not be determined.Three photographs of a powerglide pro were returned for evaluation.An initial visual observation of the photographs showed the device with the catheter detached and the needle safety was activated.The core wire of the guidewire was broken and a portion of the coil wire was unraveled.The weld tip of the guidewire appears to be intact.Use residue was observed on the sample in the returned photographs.In the returned photographs, the catheter length was held up against an orange paper ruler.The catheter was observed to be approximately 2.5 cm.The break site of the catheter was observed to be at an angle.No other details of the damage could be discerned in the returned photographs.Catheter and guidewire damage were evident in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that powerglide pro rt midline catheter was sheared off during an insertion attempt during training.5.5cm of catheter was left within the patient¿s arm.Md notified x-ray performed identified catheter in tissues, not vascular, general surgery consulted for removal.No other information was provided.

• Brand Name: BASIC KIT 20G X 8 CM WITH BIOPATCH
• 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: 17839457
• Report Number: 3006260740-2023-04354
• Device Sequence Number: 7418289
• Product Code: FOZ
• UDI-Device Identifier: 00801741140525
• UDI-Public: (01)00801741140525
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/23/2024

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: F320087T
• Device Lot Number: REHQ4281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 02/01/2024
• 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 Sex: Unknown