MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH GUARDIVA AND PROBE COVER; 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	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refw2775 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "nurse telling me there is no re- recanulate when she met resistant she removed immediately, so there was no opportunity for that to happen.This is the 28 cm device.".
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 powerglide placement complications was confirmed.The product returned for evaluation was one 20ga x 8cm powerglide pro rt midline catheter assembly.Usage residues were observe throughout the sample.The sample was received assembled with the catheter overlaying the needle shaft.The needle protruded from a split in the catheter approximately 2cm from the distal tip.The guidewire remained inlaid through the catheter.Microscopic inspection of the split in the catheter revealed a glossy fracture surface.Inspection of the distal end of the catheter revealed deformation throughout the catheter tip.The fracture features were consistent with catheter perforation by the needle tip.Such damage can occur if the catheter is pulled back onto the needle and if the needle is re-inserted following catheter advancement.The catheter tip deformation was consistent with attempted catheter advancement against resistance, such as into tissue.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "nurse telling me there is no re- recanulate when she met resistant she removed immediately, so there was no opportunity for that to happen.This is the 28 cm device.".

• Brand Name: FULL KIT 20G 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14568495
• Report Number: 3006260740-2022-02032
• Device Sequence Number: 17663543
• Product Code: FOZ
• UDI-Device Identifier: 00801741140570
• UDI-Public: (01)00801741140570
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/24/2022

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: F120088PT
• Device Lot Number: REFW2775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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