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

Catalog Number	382933
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd iag bc pro global wing package seal integrity.The following information was provided by the initial reporter, translated from french to english: i am sending you a material safety report of zero clinical importance.We found 11 units of unsealed (primary packaging unsealed) and therefore non-sterile.We have not found this defect in other boxes from the same batch.We're not asking for credit or free units, i just wanted to let you know.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of unsealed packaging was confirmed and the cause appeared to be packaging related.Two photographs and eleven 20ga insyte autoguard units from lot #2340957 were provided for investigation.The eleven units did not exhibit a complete seal due to the top web being misaligned with the bottom web.This defect likely occurred during the packaging process.During the sealing process, it appeared that the top web was misaligned with the bottom web, which resulted in an incomplete and open seal.100% vision system and setup verification per procedures are in place to mitigate the occurrence of this defect.The appropriate manufacturing personnel were notified of this issue.

• Brand Name: BD IAG BC PRO GLOBAL WING
• 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: 18951312
• Report Number: 1710034-2024-00211
• Device Sequence Number: 15430268
• Product Code: FOZ
• UDI-Device Identifier: 00382903829330
• UDI-Public: (01)00382903829330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 11/30/2025
• Device Catalogue Number: 382933
• Device Lot Number: 2340957
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown