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

Catalog Number	305950
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd safetyglide package was damaged, defective.The following information was provided by the initial reporter: "the item is damaged and no longer sterile.There is a giant hole on the top left of the item." additional information received on 02/27/24: ¿per the customer the one is in the packaging.¿.
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
Investigation summary: one tray of unused mat#305950 syringes was received with a hole in the corner of the plastic tray.The complaint has been verified and the manufacturer has been notified of this issue.Root cause of the hole in package is unknown but possible root causes include package damage by distributor mishandling or accidental damage by customer before use.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Samples received.

• 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: 18799014
• Report Number: 1920898-2024-00074
• Device Sequence Number: 20627482
• Product Code: MEG
• UDI-Device Identifier: 30382903059509
• UDI-Public: (01)30382903059509
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 3131651
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown