MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 18G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
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 be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported successfully inserted the vessel with 18-gauge needle and guidewire was deployed.After guidewire was deployed and in vein with ultrasound confirmed the powerglide catheter was inserted into the vessel.When trying to retract the guidewire out it seemed difficult to retract.When i was able to pull the powerglide out i had noticed the guidewire was curled.After the attempt to place powerglide with ultrasound the patient upper arm was scanned and we noticed that there was possibly a piece of the powerglide catheter left inside the patient arm.During the entire process the patient was asked multiple times if she was in any pain or discomfort and patient stated she was not in any pain or discomfort.I did explain the entire situation to the patient and told her what had happened.She was extremely calm and stated to be in no pain.I notified her the next step i would take would be contacting her md to explain what happened and to get confirmation.Additional information on 08/06/2024: patient had surgery to remove the piece.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 complaint of a broken catheter is confirmed, but the root cause could not be determined.One photo was returned for evaluation.The photo shows what is likely a portion of the catheter tubing of a powerglide catheter.The rest of the catheter assembly is not visible in the photo and the photo does not provide enough detail do comment further on the damage at the break site.Based on the available material for review, there were no distinguishing features in the returned media which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported successfully inserted the vessel with 18-gauge needle and guidewire was deployed.After guidewire was deployed and in vein with ultrasound confirmed the powerglide catheter was inserted into the vessel.When trying to retract the guidewire out it seemed difficult to retract.When i was able to pull the powerglide out i had noticed the guidewire was curled.After the attempt to place powerglide with ultrasound the patient upper arm was scanned and we noticed that there was possibly a piece of the powerglide catheter left inside the patient arm.During the entire process the patient was asked multiple times if she was in any pain or discomfort and patient stated she was not in any pain or discomfort.I did explain the entire situation to the patient and told her what had happened.She was extremely calm and stated to be in no pain.I notified her the next step i would take would be contacting her md to explain what happened and to get confirmation.Additional information 08/06/2024: patient had surgery to remove the piece.No other information was provided.

• Brand Name: BASIC KIT 18G 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20055074
• Report Number: 3006260740-2024-04683
• Device Sequence Number: 15483309
• Product Code: FOZ
• UDI-Device Identifier: 00801741140501
• UDI-Public: (01)00801741140501(11)240410(17)250930(10)REJP1935
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/14/2025

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F318087T
• Device Lot Number: REJP1935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: Required Intervention
• Patient Sex: Unknown