MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB; SYRINGE, ANTISTICK

Catalog Number	305950
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 305950, batch # 3341038, 4066070.It was reported that the bd syringe alrg sftygld 1ml w/ndl 27x1/2 rb needle was clogged / blocked.The following information was provided by the initial reporter: it was reported by customer that bd safety glide drew up very slow, felt pressurized when injecting, the needle felt blunt, verbatim: rcc received a complaint via email.Email(s) attached.They are the bd safety glide 1 ml 27 g x 1/2.I have 2 lot numbers.Lot#3341038: 4 drew up very slow (trickles at a time, takes forever to fill), and 2 of these felt pressurized when injecting.We also had 2 where the patients commented on how blunt the needle felt.Lot #4066070: 3 drew up slow and were pressurized when injecting.1 i could not draw up because it was going so slow and i could not get the air bubble out of the top.This is our current lot.This morning i had a patient that got 3 injections.2 of the 3 did not draw up well so i asked him if he could feel a difference and he said yes.The 2 that did not draw up well felt tingly and more painful when injecting and the other one felt fine.Item: 305950, quantity affected: (b)(4) ea.Serial/lot number: (b)(6).Po : (b)(4).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document#: (b)(4) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: safetyglide - allergy.Device failure: needle clogged / blocked.
Additional Manufacturer Narrative
Investigation summary: no photo or sample was received for the customer's complaint of needle issues.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.The manufacturer has been notified of this occurrence.No issues have been found that would affect the quality production history of this product.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21289083
• Report Number: 1920898-2025-00001
• Device Sequence Number: 7909352
• Product Code: MEG
• UDI-Device Identifier: 00382903059508
• UDI-Public: (01)00382903059508(11)240220(17)281231(10)3341038
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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,Followup
• Report Date (Section B): 03/10/2025

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 Catalogue Number: 305950
• Device Lot Number: 3341038
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided; 03/10/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/20/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown