MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE; SAFETYGLIDE NEEDLES

Catalog Number	305950
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material#: 305950, batch number#: 3289430.It was reported that the bd safetyglide safety mechanism broke.The following information was provided by the initial reporter: "safety glide falling off).Verbatim#: rcc received a complaint via email.Email(s) attached.On which customer reported defective product , for po - (b)(4).17706250 9878569 saftglde allergy tray reg 40 25/tray 9.50 380.00 82384-27 f 606605700.Serial#: lot#: 3289430 po#: 23365765 cmt: safety glide falling off.Vndr item#: (b)(4).Adtl.Cmts: exp - 11/30/28 vndr inv#: rf: pr.17709383 9878569 saftglde allergy tray reg 40 25/tray 9.50 380.00 82384-29 f 606605700.Serial#: lot#: 3289430 po#: 23365765 cmt: safety glide falling off.Vndr item#: (b)(4).Adtl.Cmts: exp - 11/30/28 vndr inv#: rf: pr.
Event or Problem Description
Samples received.
Additional Manufacturer Narrative
Investigation summary: 2000 (2 full cases) unused mat# 305950 syringes were received and tested by our quality team.200 syringes were randomly selected from the shipment and tested by flexing safety mechanism and pulling past normal mechanical stress that would be seen in a clinical setting.No failures or abnormalities were noticed after random testing.Of five separate safety shield batches that went into the production of the final syringe batch (3289430), there was one quality notification that was raised during "shield removal inspection" which is a possible root cause of the customer's experienced failure- faulty shield assemblies being included in final packaged products due to inadequate quality control protocol.This finding verifies the complaint and the manufacturer has been notified of this instance.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SAFETYGLIDE NEEDLES
• 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: 19244127
• Report Number: 1920898-2024-00115
• Device Sequence Number: 7430776
• Product Code: MEG
• UDI-Device Identifier: 30382903059509
• UDI-Public: (01)30382903059509
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/17/2024

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: 305950
• Device Lot Number: 3289430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown