MAUDE Adverse Event Report: BECTON DICKINSON 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	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte gn 18ga x 1.16in had foreign matter compromised sterility concern as unknown material attached to side of cannula.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Based on the fm material type, investigation was conducted to identify the potential fm sources.The raw materials of the product components were reviewed, and no component is using polyacetal as the raw material.The assembly process was reviewed.Upon checking, there was no transparent, loose polyacetal material found near the manufacturing areas.All the machines on the production line are fully covered, surfaces that are in contact with product are cleaned periodically per the cleaning schedule.Furthermore, there was no cannula tip damage observed on the returned sample, hence it was unlikely that the long, coiled up fm was introduced by the cannula skiving off material it was in contact with.The fm most likely dropped on the cannula tip.With no poly(acetal) material used to manufacture the product components, and no loose polyacetal material found near the machines, the actual foreign matter source could not be identified.As the sample was returned in open packaging, actual root cause could not be established.Based on the complaint history review, this is the first fm complaint reported for this batch.Hence, this is most likely an isolated case.As current control, there is an outgoing inspection and in-process inspection in place to check for foreign matter.There is also a 4-hourly housekeeping in place to clean all the machine mechanisms in direct contact with products with alcohol (70% ipa).
Event or Problem Description
Compromised sterility concern as unknown material attached to side of cannula.

• Brand Name: BD INSYTE GN 18GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19304353
• Report Number: 2243072-2024-00622
• Device Sequence Number: 7337454
• Product Code: FOZ
• UDI-Device Identifier: 00382903812448
• UDI-Public: (01)00382903812448
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: 381244
• Device Lot Number: 3293950
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown