MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte bl 22ga x 1.0in connector / hub - not able to connect to mating component the following information was provided by the initial reporter: the blue catheter hub does not allow a connector cap to be screwed on to it.Requires patient to be re-cannulated.Found by several of the anaesthetic team.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned 1 actual sample and 2 representative samples, observed damaged adapter outer luer thread.The damage locations were different in relative to the side of the adapter.The luer damage on the actual sample was found at the side of mold cavity number, whereas it was found at the ejector pin mark for the representative samples.As the defect was not found at the same location and not the same mold cavity number, the defect was most probably caused during the assembly process instead of the adapter molding process.The assembly process was reviewed.It was suspected that this defect was caused at the tipper.The most probable cause was the minor misalignment of the picker height between different stations in the tipper, which caused the adapter to be over-inserted during pick and place and damaged the outer luer thread.Proposed action plan: 1.Conduct complaint awareness training and communication to all insyte tipper production technicians (pts), and to monitor the occurrence of the adapter damaged outer luer thread defect.2.Retrain all insyte tipper pts on pickers height alignment in tipper procedure.Effectiveness check plan: no.Description of effectiveness check plan assigned to due date 1.After communication, interview 3 insyte tipper pts from different shifts randomly over a period of 1 month to check understanding of damaged outer luer thread defect.2.After communication and retraining, monitor 3 consecutive insyte assembled needle (an) batches for re-occurrence of damaged outer luer thread defect during in-process and outgoing inspections.(acceptance criteria = zero re-occurrence).
Event or Problem Description
The blue catheter hub does not allow a connector cap to be screwed on to it.Requires patient to be re-cannulated.Found by several of the anaesthetic team.

• Brand Name: BD INSYTE BL 22GA X 1.0IN
• 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: 18839309
• Report Number: 2243072-2024-00251
• Device Sequence Number: 7485387
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 3279818
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown