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

Catalog Number	392533
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/26/2024
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 incomplete needle retraction.The following information was provided by the initial reporter: safety mechanism did not work as intended.Needle did not retract all the way into the housing leaving the contaminated sharp exposed.
Event or Problem Description
Additional information from customer: there was 2 needlesticks to nurses.
Additional Manufacturer Narrative
Investigation results: the complaint that the needle failed to fully retract was confirmed; however, the root cause could not be determined from the photographs that were provided for investigation.One photo showed just a short section of the needle extending from the grip, which indicated that the safety mechanism was activated and the needle was partially retracted.This type of damage can occur if the barrel is damaged, which prevents full retraction of the needle hub and needle.The barrel is being held in the photo, which obscured a portion of the needle hub and barrel.The root cause of the reported issue could not be determined from the photo.A device history record review showed no non-conformances associated with this issue during the production of the reported production batches.Complaints received for this device and reported condition will continue to be tracked and trended.

• 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) ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 19169763
• Report Number: 1710034-2024-00347
• Device Sequence Number: 7949147
• Product Code: FOZ
• UDI-Device Identifier: 00382903925339
• UDI-Public: (01)00382903925339
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 392533
• Device Lot Number: 4012524
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown