MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
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 " end popped off actual loop".No other information was provided.
Event or Problem Description
It was reported " end popped off actual loop".No other information was provided,.
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 extension set was confirmed.The product returned for evaluation was one powerglide pro midline catheter extension set.Usage residues were observed throughout the sample and a needleless injection cap was attached to the female luer adapter.A complete break was observed in the extension tubing at the luer/tubing joint.Microscopic inspection of the break revealed a granular fracture surface.Beach marks were observed throughout regions of the break surface.Deformation, material flow and buckling were observed in the vicinity of the break surface.The break features and material buckling were consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs when repetitive mechanical forces such as twisting and kinking gradually cause a fracture to form and propagate.The location of the damage suggested that device securement, access and maintenance techniques may have contributed.

• Brand Name: FULL KIT 20G X 10 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15136253
• Report Number: 3006260740-2022-02979
• Device Sequence Number: 5323727
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120108PT
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/07/2022
• 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: Other
• Patient Sex: Unknown