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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that midline got stuck in the patient.The surgeon had to come and remove it.Additional info received on 15-june-23: surgery had to be called to remove catheter.The event happened at time of placement.When inserting the midline, the guidewire and catheter advanced without any resistance but upon trying to retract the guidewire it would not retract.Heat packs were applied and minimal force to try to pull entire midline out with no success.In fear of a portion of the midline breaking off inside the patient surgery was called for safe removal.Complainant was unsure if the event interrupt the administration of any medication, or cause a clinically significant delay in medication.Ultrasound was used during the event.
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 device has not been returned to the manufacturer for evaluation.
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.
Event or Problem Description
It was reported by the customer that midline got stuck in the patient.The surgeon had to come and remove it.Additional info received on 15-june-2023.Surgery had to be called to remove catheter.The event happened at time of placement.When inserting the midline, the guidewire and catheter advanced without any resistance but upon trying to retract the guidewire it would not retract.Heat packs were applied and minimal force to try to pull entire midline out with no success.In fear of a portion of the midline breaking off inside the patient surgery was called for safe removal.Complainant was unsure if the event interrupt the administration of any medication, or cause a clinically significant delay in medication.Ultrasound was used during the event.
Event or Problem Description
It was reported by the customer that midline got stuck in the patient.The surgeon had to come and remove it.Additional info received on 15-june-23.Surgery had to be called to remove catheter.The event happened at time of placement.When inserting the midline, the guidewire and catheter advanced without any resistance but upon trying to retract the guidewire it would not retract.Heat packs were applied and minimal force to try to pull entire midline out with no success.In fear of a portion of the midline breaking off inside the patient surgery was called for safe removal.Complainant was unsure if the event interrupt the administration of any medication, or cause a clinically significant delay in medication.Ultrasound was used during the event.
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 difficulty removing the guidewire of a powerglide pro is confirmed and was determined to be use related.One 22 ga powerglide pro was returned for evaluation.The guidewire in the returned powerglide pro was observed to have disjointed coils throughout the distal end of the guidewire, and the guidewire was observed to have sharp bends coming out of the distal end of the needle.Based on the sharp bends and disjointed coils observed along the returned guidewire of the powerglide pro, the complaint of difficult device removal is confirmed.Insertion into resistance such as tissue can cause damage to the guidewire thus causing difficulty during removal of the guidewire.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: DOT PG PRO 22G 8CM 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: 17183744
• Report Number: 3006260740-2023-02565
• Device Sequence Number: 6462094
• Product Code: FOZ
• UDI-Device Identifier: 00801741152771
• UDI-Public: (01)00801741152771
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 11/09/2023

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F322088PTX
• Device Lot Number: REHQ2339
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 11/09/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/10/2023; 11/14/2023
• 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: 8 YR
• Patient Sex: Female
• Patient Race: White