MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 2209959.D4.Medical device expiration date: 31jul2027.H4.Device manufacture date: 19aug2022.D4.Medical device lot #: 2273054.D4.Medical device expiration date: 30sep2027.H4.Device manufacture date: 21oct2022.H3.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 that the needle went through 4 boxes of the bd insyte¿ autoguard¿ shielded iv catheter.The following was received from the initial reporter: we have the following product that is defective.
Additional Manufacturer Narrative
A device history record review was completed for provided material number (b)(4) and lot numbers 2209959 and 2273054.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, three (3) samples and one (1) picture sample were returned for evaluation by our quality team.Through examination of the samples, the needle was found through the catheter component.Although no issues were identified during the production process, it is most likely that the observed defect resulted from an improper adjustment of the manufacturing station; causing the fittings to not be adjusted for catheter length and the vision system to be not properly configured.Further investigation and actions for the issue of needle through catheter will be conducted through a corrective and preventive action plan initiated.
Event or Problem Description
Additional info from customer: 07-sep-2023 4 boxes (50/box) of 22g catheters (we removed all catheters from use) reported on aug 31,2023 no adverse effects that we know of.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora 81460 ; BR 81460
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17777032
• Report Number: 9610048-2023-00095
• Device Sequence Number: 6169899
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: (01)30382903812234
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: Other
• Device Catalogue Number: 381223
• Device Lot Number: 2273054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 01/23/2024
• 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
• Patient Sex: Unknown