MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD IVSS BLUE IV ACC WO TEGADERM MED GLVS; INTRAVASCULAR CATHETER

Catalog Number	386172
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd ivss blue iv acc wo tegaderm med glvs expired product received 357.13bx ( (b)(4) ea ) expired with guarantee letter.This report is expired product with guarantee letter issued by becton dickinson, there are 3 lot numbers with the same article.The following are the expired item with corresponding lot number and quantity : 2278835- (b)(4) ea, 2278838-28,(b)(4) ea, 2278840- (b)(4) ea.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The reported issue has been identified as a customer service issue and is not a product related issue.

• Brand Name: BD IVSS BLUE IV ACC WO TEGADERM MED GLVS
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20276042
• Report Number: 9610847-2024-00274
• Device Sequence Number: 20661840
• Product Code: LRS
• UDI-Device Identifier: 30382903861720
• UDI-Public: (01)30382903861720(11)221013(17)240731(10)2278840
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 386172
• Device Lot Number: 2278840
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown