MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 20G 10CM RT; 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	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regu2348 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer, "i stuck the patient followed it on ultrasound unti i was in the middle, inserted the wire no issues then the catheter had resistance so i went to remove had resistance so another nurse tried and that is when we realized the catheter had broke off.Patient had to go to ir to retrieve the catheter.".
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.One 22 ga x 8 cm powerglide pro midline catheter was returned for evaluation.An initial visual observation showed use residues throughout the returned powerglide device, and the needle was advance with the catheter crumpled around the needle.A microscopic observation revealed a complete catheter break about 1.5 cm from the molded joint.The distal fragment was observed to be severely crumpled and compressed at the needle tip, as the needle tip was part way through the catheter.The needle tip location proved to be an additional puncture site.Sharp puncture marks coincide with the shape of the needle bevel along the catheter.The needle puncture sites are indicative of the catheter being advanced prematurely or the needle advancing further after the catheter was advanced.The complaint of a broken catheter is confirmed.Observations of the catheter revealed incorrect needle/catheter interactions as sharp imprints along the catheter near the break were observed.
Event or Problem Description
It was reported by the customer, "i stuck the patient followed it on ultrasound unti i was in the middle, inserted the wire no issues then the catheter had resistance so i went to remove had resistance so another nurse tried and that is when we realized the catheter had broke off.Patient had to go to ir to retrieve the catheter.".

• Brand Name: DOT PG PRO 20G 10CM RT
• 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: 16250236
• Report Number: 3006260740-2023-00141
• Device Sequence Number: 6552329
• Product Code: FOZ
• UDI-Device Identifier: 00801741152764
• UDI-Public: (01)00801741152764
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: F320108PTX
• Device Lot Number: REGU2348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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