MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK; SAFETYGLIDE NEEDLE

Catalog Number	305900
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.E.1.Address is b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd safety-lok needles were clogged/blocked.The following information was provided by the initial reporter: "very difficult to push medication through the above lot of bd safetyglide 22 g needles." problem: 1.It may be very difficult to push medication through the above lot of bd safetyglide 22 g needles.2.The defective needles may cause patient and administrator discomfort.3.The force required to administer the injection may cause medication leakage and patient injury.Bd safetyglide 25 g x 1-inch needles : lot =2025239 25 g x 1-inch safetyglide shielding hypodermic needles ref# (b)(4), lot = regn2117.Safetyguide shielding hypodermic needles ref# (b)(4), lot=1160596.
Event or Problem Description
Materials#: 305900 batch#: 1160596 verbatim: rcc received a complaint via email.Email(s) attached.Problem: 1.It may be very difficult to push medication through the above lot of bd safetyglide 22 g needles.2.The defective needles may cause patient and administrator discomfort.3.The force required to administer the injection may cause medication leakage and patient injury.Bd safetyglide 25 g x 1-inch needles: lot =2025239 25 g x 1-inch safetyglide shielding hypodermic needles ref#(b)(4) lot = regn2117 safetyguide shielding hypodermic needles ref# (b)(4) lot=1160596 per customer response 03jan2024: is this in regard to the bd safetyglide 25g x 1¿ needles? we do not carry the 22g.I did not place a report that it was difficult to push a medication through.There was a recall on some lot numbers of bd safetyglide 25g x 1¿ needles and i reported to my logistics team that though i did not have those specific lots, i felt the needles and safety were flimsy on this brand, with a potential risk for needle sticks.
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.

• Brand Name: BD SAFETY-LOK
• Common Device Name: SAFETYGLIDE NEEDLE
• 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: 18540105
• Report Number: 1213809-2024-00010
• Device Sequence Number: 7699458
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: (01)30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/03/2024

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: 05/31/2026
• Device Catalogue Number: 305900
• Device Lot Number: 1160596
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown