MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE MIDLINE CATHETER 20G 10CM FULL INSERTION KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "two lines split about an inch from the tip during insertion." no other information was provided, this report addresses the second device.
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.
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, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damaged midline catheters was confirmed.The product returned for evaluation was two 20ga x 8cm powerglide pro midline catheters.Usage residues were observed throughout both samples.Both catheters had been advanced and were received without their placement assemblies.Both samples exhibited diagonal splits approximately 1.5cm from the distal tip.Microscopic inspection of the splits revealed partially dull and partially reflective fracture surfaces.The fracture edges were sharply defined.Longitudinally aligned scoring marks were observed leading into both fracture sites.Microscopic inspection of the catheter tips revealed deformation.The tip edges were flared and buckled.Additional catheter buckling was observed near the catheter tips.The split features were consistent with damage caused by contact between the catheters and the introducer needle tips.Such damage can occur if the catheters are pulled back onto the needles and if the needles are reinserted following catheter advancement.The tip deformation suggested that attempted insertion against resistance, such as into tissue, may have contributed.
Event or Problem Description
It was reported by the customer that "two lines split about an inch from the tip during insertion." no other information was provided.This report addresses the second device.

• Brand Name: POWERGLIDE MIDLINE CATHETER 20G 10CM FULL INSERTION KIT
• 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: 16112013
• Report Number: 3006260740-2023-00009
• Device Sequence Number: 5846819
• Product Code: FOZ
• UDI-Device Identifier: 00801741075308
• UDI-Public: (01)00801741075308
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: M020101
• 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): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/24/2023
• 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