MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC GLOBAL; PERIPHERAL IV CATHETERS

Catalog Number	381033
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autog bc global needle did not retract.The following information was provided by the initial reporter, translated from japanese to english: this is a report about needle retraction failure.When customer pressed the button to retract the puncture needle, it did not work.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unsealed 20ga x 1.00in.Insyte autoguard bc unit from lot number 4193406.Additionally, 4 photos were provided.A visual inspection was performed on the physical sample provided and discovered that there was media present, indicating use.Your report that the needle would not fully retract was confirmed and the cause appeared to be manufacturing related.Deformation on the needle hub appeared to prevent the needle from fully retracting into the shield (barrel/grip).The damage likely occurred during the assembly process.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOG BC GLOBAL
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21270020
• Report Number: 1710034-2025-00092
• Device Sequence Number: 3916097
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: (01)00382903810338(11)240718(17)270630(10)4193406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: Health Professional
• Device Catalogue Number: 381033
• Device Lot Number: 4193406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown