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

Catalog Number	381234
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ iv catheter experienced foreign matter in fluid path.The following information was provided by the initial reporter: two foreign particles were detected by the doctor when placing the cannula, they were located on the cannula bevel / on the aperture of the cannula, at the beginning of the cannula.
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.D.4 device expiration date: unknown.H.4 device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-jul-2023.H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unsealed 20ga x 1.16in.Insyte autoguard bc unit.Additionally, 3 photos were provided.Visual inspection discovered that the unit had a small solid brown foreign matter on the bevel of the needle.Since the foreign matter was discovered in the fluid path, it was sent for spectral analysis.There was no definitive identification of the foreign matter discovered but it most closely matched an unknown silicone-based polymer.The reported issue was confirmed.This foreign material may have been introduced during packaging or manufacturing as a result of environmental factors, incoming material, or personnel.To mitigate the occurrence of these defects: operators perform cleaning per the quality plan, good manufacturing practices and gowning are followed, and environmental controls and inspections for foreign matter are performed per the quality control and sampling plans.Although, the package was unsealed, the foreign matter was discovered inside the needle cover and on the bevel of the needle upon opening of the package.This most likely occurred during manufacturing.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
Event or Problem Description
It was reported that the bd insyte¿ iv catheter experienced foreign matter in fluid path.The following information was provided by the initial reporter: two foreign particles were detected by the doctor when placing the cannula, they were located on the cannula bevel / on the aperture of the cannula, at the beginning of the cannula.

• Brand Name: BD INSYTE¿ 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17075740
• Report Number: 8041187-2023-00255
• Device Sequence Number: 17812291
• Product Code: FOZ
• UDI-Device Identifier: 00382903812349
• UDI-Public: (01)00382903812349
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 381234
• Device Lot Number: UNKNOWN
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/12/2023
• 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