MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 8 CM WITH GUARDIVA AND PROBE COVER; 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	09/10/2022
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the customer that the "patient had powerglide inserted in the brachial vein for almost a month.Contact was alerted that the catheter has completely fractured at the distal end of the catheter.Nurse removed catheter hub but vascular decided to leave the catheter in place and monitor it from outpatient and only remove if necessary.They had not been using the catheter for a few weeks and the patient is active in a wheelchair.".
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged midline catheter was confirmed.The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter.Usage residues were observed throughout the catheter and an extension set was attached to the luer adapter.The catheter terminated approximately 1cm from the molded joint.The distal catheter fragment was not returned.Microscopic inspection of the break site revealed a granular fracture surface.Material wear was observed along part of the fracture surface.Material compression, buckling and discoloration were observed in the vicinity of the break.The break exhibited an elliptical cross section.The catheter fracture features were consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tubing gradually causing a split to form and propagate.The location of the damage suggested that catheter placement and securement techniques may have contributed.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer that the "patient had powerglide inserted in the brachial vein for almost a month.Contact was alerted that the catheter has completely fractured at the distal end of the catheter.Nurse removed catheter hub but vascular decided to leave the catheter in place and monitor it from outpatient and only remove if necessary.They had not been using the catheter for a few weeks and the patient is active in a wheelchair." additional information: event information what type of catheter securement was utilized? statlock pro.Placement date: (b)(6) 2022.Explant date: (b)(6) 2022.Patient information (if available) what they¿re being treated for: mva trauma.Additional questions: is the 'hub' referring to the needleless injection cap? no, catheter hub, where the extension set attaches to.Since the hub of the catheter was removed, is the catheter break under the skin? is there any piece of the catheter that is left open to air? yes the break was under the skin.Remaining catheter was in the vessel.How is the catheter being monitored? outpatient with vascular surgery team.

• Brand Name: FULL KIT 18G X 8 CM WITH GUARDIVA AND PROBE COVER
• 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: 15506796
• Report Number: 3006260740-2022-03826
• Device Sequence Number: 12029408
• Product Code: FOZ
• UDI-Device Identifier: 00801741140556
• UDI-Public: (01)00801741140556
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/01/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118088PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male