MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381244
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	02/02/2022
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 insyte gn 18ga x 1.16in, the device experienced foreign matter at the tip of the cannula.The following information was provided by the initial reporter.The customer stated: staff went to cannulate patient and noticed a fine thread attached to the tip of the cannula.Another cannula was used to cannulate pt, however staff retained the other cannula for collection.
Event or Problem Description
It was reported when using the bd insyte gn 18ga x 1.16in, the device experienced foreign matter at the tip of the cannula.The following information was provided by the initial reporter.The customer stated: staff went to cannulate patient and noticed a fine thread attached to the tip of the cannula.Another cannula was used to cannulate pt, however staff retained the other cannula for collection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 14-feb-2022.H.6.Investigation: two photos and one sample were with open packaging was received by our quality team for evaluation.The photos were subjected to visual inspection to check for foreign matter.A strip of loose, transparent foreign matter was observed on the catheter tip.The sample was subjected to visual inspection.A strip of loose, transparent foreign matter approximately 4 mm long was observed on the catheter tip.The foreign matter was sent for fourier transform infrared spectroscopy (ftir) analysis to determine the foreign matter type.The results indicated the foreign matter as polypropylene.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the foreign matter, an investigation was conducted to identify the potential foreign matter sources.The personal protective equipment (ppe) used in the production area were looked into to identify those with similar characteristics of the foreign matter.Based on the ftir analysis, the hair net and beard cover are made of polypropylene material, however the fibers of the hair net and beard cover are white in color, and do not match the transparent appearance of the foreign matter.The assembly process was reviewed, and it was observed that all the machines are fully covered, with clean machine surfaces and machine beds without polypropylene-based materials.The manufacturing process is highly automated with minimal human intervention.As the sample was returned in open packaging, the actual root cause could not be established.H3 other text : see h.10.

• Brand Name: BD INSYTE GN 18GA X 1.16IN
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13544630
• Report Number: 8041187-2022-00083
• Device Sequence Number: 2187424
• Product Code: FOZ
• UDI-Device Identifier: 00382903812448
• UDI-Public: 00382903812448
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/31/2022

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: 03/31/2026
• Device Catalogue Number: 381244
• Device Lot Number: 1078994
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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