MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SLIDE CLOSE CHEMO 9GAL; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material #:305604, batch#:unknown.It was reported by customer that the lids are not closing/locking correctly.Verbatim: rcc received a complaint via email.Email(s) attached.Please be advise our customer is reporting a product complaint for item 305604.The lids are not closing/locking correctly.Below is a screenshot of the photos provided by the customer.Are returns needed for further research? one of our po's the product was ordered by is 4531929349.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.This complaint was found to be a duplicate after the mdr was submitted, please refer to (b)(4).
Event or Problem Description
No additional information was provided.

• Brand Name: SHARPS COLL SLIDE CLOSE CHEMO 9GAL
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18968856
• Report Number: 2243072-2024-00438
• Device Sequence Number: 12332215
• Product Code: FMI
• UDI-Device Identifier: 00382903056040
• UDI-Public: (01)00382903056040
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 09/25/2024

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 Catalogue Number: 305604
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown