MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; SAFETYGLIDE NEEDLES

Catalog Number	306616
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd safetyglide needle was clogged/blocked.The following information was provided by the initial reporter: "i received a complaint on the below product.When the needle is luered on, it is requiring extreme pressure to prime out air in needle.There appears to be something blocking or in syringe, possibly a small piece of plastic.This has happened with multiple lots.Please advise what we should do.Is this just a bad lot?" verbatim: rcc received a complaint via email.Email(s) attached.There appears to be something blocking or in syringe, possibly a small piece of plastic.Lot#: 3300424.Product: needle, sfty 192-n251s preventsg org 25gx1".
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
Material#: 306616 , batch#: 3300424.It was reported by the customer that appears to be something blocking or in syringe, possibly a small piece of plastic.Verbatim: rcc received a complaint via email.Email(s) attached.There appears to be something blocking or in syringe, possibly a small piece of plastic.Lot#: 3300424.Product: needle, sfty 192-n251s preventsg org 25gx1".Comments on (b)(6) 2024.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SAFETYGLIDE NEEDLES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19076284
• Report Number: 1213809-2024-00210
• Device Sequence Number: 17867530
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 05/17/2024

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 Catalogue Number: 306616
• Device Lot Number: 3300424
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown