MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported, "during placement of midline, accessed left cephalic vein.Upon advancing the catheter and retracting the needle, catheter broke off into patient's arm.Patient was brought to ir and the catheter fragment was successfully retrieved by physician.Original midline device was placed in sharps bin and is unable to be retrieved.No patient concerns once x-ray confirmed they did not see wire fragments." no other information was provided.

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.

Event Description

It was reported, "during placement of midline, accessed left cephalic vein.Upon advancing the catheter and retracting the needle, catheter broke off into patient's arm.Patient was brought to ir and the catheter fragment was successfully retrieved by physician.Original midline device was placed in sharps bin and is unable to be retrieved.No patient concerns once x-ray confirmed they did not see wire fragments".No other information was provided.Additional information received: the patient was transferred to interventional radiology and the catheter fragment was successfully retrieved by the radiologist.No harm to the patient.

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 and was determined to be use related.One catheter segment from a powerglide pro was returned for evaluation.An initial visual observation showed blood use residues throughout the returned catheter fragment.A chevron-shaped break in the catheter was observed at the proximal end of the returned fragment.A microscopic observation revealed a granular fracture surface and sharp fracture edges of the split in the catheter.The observed characteristics of the split are typically caused by pulling the catheter back against the needle bevel during the insertion process.The complaint of a break in the catheter is confirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings in section h11.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM)
• Type of Device: 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19014522
• MDR Text Key: 339051094
• Report Number: 3006260740-2024-01382
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120080T
• Device Lot Number: REHW2045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention