MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381323
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke when the needle was withdrawn and the tip was thickened.The following was received by the initial reporter: when the needle is withdrawn, the catheter breaks.You notice that the tip of the catheter is thickened.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-sep-2023.H6: investigation summary our quality engineer inspected the photos and representative samples of another lot submitted for evaluation.The reported issue of catheter broken was not confirmed upon inspection and testing of the samples.Analysis of the sample showed no damage to the catheter tip.All the samples also passed the catheter to adapter pull test with the pull forces within the specifications.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the representative samples.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke when the needle was withdrawn and the tip was thickened.The following was received by the initial reporter: when the needle is withdrawn, the catheter breaks.You notice that the tip of the catheter is thickened.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17546844
• Report Number: 8041187-2023-00438
• Device Sequence Number: 15345954
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: (01)30382903813231
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/17/2023

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: Other
• Device Catalogue Number: 381323
• Device Lot Number: 2357982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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