MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4.5F MICROEZ MICROINTRODUCER KIT; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported, "i was placing a picc line in the above patient.I was preparing to put the picc line through the introducer sheath and twisted and pulled to remove the dilator from the introducer sheath.The part of the dilator that you hold on to broke free from the dilator and left the remainder of the dilator inside the introducer sheath.I was able to safely remove the dilator from the sheath by grabbing on to the portion of dilator still protruding from the end of the sheath (fortunately a few millimeters of dilator was exposed).From this point i was able to resume placing the picc without any further incident.There was no patient injury.".
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 complaint of a break in the microintroducer is confirmed and was determined to be manufacturing related.One 4.5 fr microez micro introducer without its gray sheath was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned product.The plastic dilator portion of the micro introducer was broken off the luer just distal of the luer threads.A microscopic observation revealed a smooth fracture surface at the break site.The distal break site appeared to have slightly deformed fracture edges that appeared to be slightly mushroomed in appearance.No sharp bends were observed along the device.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, "i was placing a picc line in the above patient.I was preparing to put the picc line through the introducer sheath and twisted and pulled to remove the dilator from the introducer sheath.The part of the dilator that you hold on to broke free from the dilator and left the remainder of the dilator inside the introducer sheath.I was able to safely remove the dilator from the sheath by grabbing on to the portion of dilator still protruding from the end of the sheath (fortunately a few millimeters of dilator was exposed).From this point i was able to resume placing the picc without any further incident.There was no patient injury.".

• Brand Name: 4.5F MICROEZ MICROINTRODUCER KIT
• Common Device Name: INTRODUCER, CATHETER
• 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: 19274733
• Report Number: 3006260740-2024-02236
• Device Sequence Number: 15037511
• Product Code: DYB
• UDI-Device Identifier: 00801741038235
• UDI-Public: (01)00801741038235
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• 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): 07/10/2024

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 Expiration Date: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 0228945
• Device Lot Number: REHR2032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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