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

Catalog Number	392523
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd iag bc pro did not retract the following information was provided by the initial reporter: a few complaints that the needle won't retract.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Investigation results: 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.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
No additional information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint that the needle wouldn't retract could not be confirmed from the representative 22ga insyte autoguard bc units that were received in sealed packaging from lot #3222379.A functional test showed that the needles fully retracted when the safety mechanism was activated.No damage or defects were noted on the returned samples.Although the representative samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

• 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: 18461411
• Report Number: 1710034-2023-01512
• Device Sequence Number: 14228313
• Product Code: FOZ
• UDI-Device Identifier: 00382903925230
• UDI-Public: (01)00382903925230
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 392523
• Device Lot Number: 3222379
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 03/28/2024; 06/26/2024
• Initial Report FDA Received Date: 01/07/2024
• Supplement Report FDA Received Date: 04/05/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown