MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO; PERIPHERAL IV CATHETERS

Catalog Number	392534
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd iag bc pro needle did not retract.The following information was provided by the initial reporter: i wanted to reach out to you about our iv catheters from bd.I have received multiple complaints about the catheter not retracting.
Additional Manufacturer Narrative
Investigation results.Our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph of the implicated 20g insyte autoguard bc iv catheter.The catheter was still attached to the safety shield and the needle had not been retracted.The device contained evidence of clinical use including red residual material within the catheter tubing, catheter adaptor, and the flash chamber of the needle shield.The white activation button did not appear to be depressed in the photograph.Functional testing of the activation button could be conducted without examination of the physical sample.The needle tip was seen protruding through the side of the catheter tubing near the distal end of the catheter.The catheter tubing was bent where the needle exited out of the tubing.This type of damage results when the needle perforates the catheter wall.The location of the perforation had occurred between the needle notch and the needle bevel.As the device showed evidence of use, the catheter perforation likely occurred during clinical use.A device history record review showed no non-conformances associated with this issue during the production of this batch.We appreciate you taking the time to bring this observation to our attention.
Event or Problem Description
No additional information.

• Brand Name: BD IAG BC PRO
• 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: 19181783
• Report Number: 1710034-2024-00353
• Device Sequence Number: 20657650
• Product Code: FOZ
• UDI-Device Identifier: 00382903925346
• UDI-Public: (01)00382903925346
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 392534
• Device Lot Number: 3276441
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown