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 Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regt0508 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that the catheter sheared off.Nurse manager of picc team states that on 9-27, 2022, one of her nurses was performing a catheter exchange for a midline and the catheter sheared off.The nurse was able to see the tip of the catheter in the patient's "fatty tissue" using an ultrasound device.An x-ray was performed that verified the tip of the catheter.She reports no current patient issues.
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 following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a powerglide pro catheter being ¿sheared off¿ was confirmed.Two 18 ga x 10 cm catheters from a powerglide pro were returned for evaluation.One catheter extended 10 cm.The second catheter extended 6.2 cm and was returned with the catheter wings.The product sticker label indicates lot: regt0508.The second catheter appeared to be the same which experienced the reported complaint of shearing.Microscopic inspection of the break surface revealed a "v" shaped section of the split.The split then appeared to have propagated into a complete circumferential break leading to a complete fracture.The fractured segment was not returned.The characteristics of the damage observed are consistent with damage caused by retraction of the catheter against the needle after initial insertion.The product instructions for use (ifu) warns, "warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter." since a complete fracture in the catheter was found to be present, the complaint is confirmed.
Event or Problem Description
It was reported by the customer that the catheter sheared off.Nurse manager of picc team states that on (b)(6) 2022, one of her nurses was performing a catheter exchange for a midline and the catheter sheared off.The nurse was able to see the tip of the catheter in the patient's "fatty tissue" using an ultrasound device.An x-ray was performed that verified the tip of the catheter.She reports no current patient issues.Additional information received: patient harm reported as retained catheter fragment in right upper arm tissue, noted after procedure aborted.No complaints of pain from patient.It was stated the catheter tip was able to be removed from the patient.Surgery was required to remove the catheter top.A new device was not placed.Patient being treated for hypoglycemia.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15629406
• Report Number: 3006260740-2022-04046
• Device Sequence Number: 7970238
• Product Code: FOZ
• UDI-Device Identifier: 00801741142659
• UDI-Public: (01)00801741142659
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F118100T
• Device Lot Number: REGT0508
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 118 KG