MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM); 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	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the nurse was discontinuing midline, patient was being discharged.The nurse removed the dressing and when she pulled back on the hub of the midline it was not attached to the catheter.The nurse states there was very little catheter sticking out from the hub.She called clinician to bedside; clinician could not visualize any external catheter.Clinician placed a tourniquet in the patient's axilla and visualized the catheter with ultrasound.The patient's arm is not swollen, red or tender.There were no indications that the catheter had become dislodged prior to removal of midline.Vascular surgeon contacted and plans for surgery this afternoon to attempt removal.Patient was taken to surgery and midline catheter was removed.Clinician does not have a note from the vascular surgeon stating exactly how it was removed, but the hospitalist told clinician he was able to get it out without making any new incision.The patient was then discharged home at 2100 with a gauze dressing over the site.
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 evaluate.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.The complaint of a broken catheter is confirmed but the exact cause could not be determined.Two photographs of a broken catheter from an 18 ga powerglide pro was returned for evaluation.An initial visual observation of the photograph titled sample hub showed a powerglide pro catheter hub with the catheter broken off just distal of the green hub.The catheter break was circumferentially aligned with only a small portion of catheter remaining distal of the green hub.Use residues were observed in both the returned photos.The photograph titled sample cath showed the remaining distal portion of the catheter covered in blood and detached from the catheter hub.A bend in the distal end of the catheter was observed.Because the details of the break site could not be observed, the complaint of a broken catheter is confirmed but the root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that the nurse was discontinuing midline, patient was being discharged.The nurse removed the dressing and when she pulled back on the hub of the midline it was not attached to the catheter.The nurse states there was very little catheter sticking out from the hub.She called clinician to bedside; clinician could not visualize any external catheter.Clinician placed a tourniquet in the patient's axilla and visualized the catheter with ultrasound.The patient's arm is not swollen, red or tender.There were no indications that the catheter had become dislodged prior to removal of midline.Vascular surgeon contacted and plans for surgery this afternoon to attempt removal.Patient was taken to surgery and midline catheter was removed.Clinician does not have a note from the vascular surgeon stating exactly how it was removed, but the hospitalist told clinician he was able to get it out without making any new incision.The patient was then discharged home at 2100 with a gauze dressing over the site.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17814710
• Report Number: 3006260740-2023-04285
• Device Sequence Number: 16719795
• Product Code: FOZ
• UDI-Device Identifier: 00801741142659
• UDI-Public: (01)00801741142659
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: F118100T
• Device Lot Number: REHS4794
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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