MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD ANGIOCATH YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Model Number	381112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd angiocath yel 24ga x 0.75in, the device experienced a needle through catheter while introducing the catheter.This event occurred twice.The following information was provided by the initial reporter.The customer stated: the hcp performed venipuncture twice but the result was the same for both (the hcp could not retract the needle).The hcp could move the needle inside the catheter.
Event or Problem Description
It was reported when using the bd angiocath yel 24ga x 0.75in, the device experienced a needle through catheter while introducing the catheter.This event occurred twice.The following information was provided by the initial reporter.The customer stated: the hcp performed venipuncture twice but the result was the same for both (the hcp could not retract the needle).The hcp could move the needle inside the catheter.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-16.H6: investigation summary.Bd received a 24 gauge angiocath device from an unknown lot for evaluation.A review of the device history record could not be performed as the reported lot was unknown.Our quality engineer visually inspected the returned unit and observed a small dent in the body of the cannula.It should be noted that the product design does not have a safety device for needle retraction, the difficulty of removing the cannula from the catheter may have occurred because the cannula is dented.Based off the visual inspection the engineer was able to verify the reported claim.It was determined that the dent in the cannula came from a misalignment between the cannula and the manufacturing equipment.This misalignment caused a dent in the cannula and caused the needle to be difficult to disengage.The manufacturing facility has been notified of this incident and the findings.Adjustments have been made to the manufacturing equipment to prevent recurrence of this situation.

• Brand Name: BD ANGIOCATH YEL 24GA X 0.75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13004346
• Report Number: 3003916417-2021-00371
• Device Sequence Number: 19912517
• Product Code: FOZ
• UDI-Device Identifier: 30382903811121
• UDI-Public: 30382903811121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 381112
• Device Catalogue Number: 381112
• Device Lot Number: 9178309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2019
• 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
• Patient Sex: Unknown