MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 27X3/8 IB; PISTON SYRINGE

Catalog Number	305541
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.E.1.Address was not located and il 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
Material # 305541 batch # 3158601.It was reported that the syringe allergy 1ml w/ndl 27x3/8 ib had mixed product /lots.The following information was provided by the initial reporter: it was reported by customer that the needles are dull mixed lots.Rcc received a complaint via email.Needles are dull mixed lots.
Additional Manufacturer Narrative
Investigation summary: 32 unused needle trays were received and tested with the customer's complaint of dull needles.The 800 needles were individually analyzed under high power digital microscope to assess needle tips for possible abnormalities.None of the 800 needles presented with any issues.The manufacturer was notified of this issue.Without further information like the affected sample for investigation- the complaint cannot be verified and the root cause remains unknown.
Event or Problem Description
Samples received.
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)(6)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir 10000690801.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: allergy syringe; device failure: mixed product / lots.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 27X3/8 IB
• Common Device Name: PISTON SYRINGE
• 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: 20767537
• Report Number: 1920898-2024-00153
• Device Sequence Number: 9264500
• Product Code: FMF
• UDI-Device Identifier: 00382903055418
• UDI-Public: (01)00382903055418(11)230607(17)280630(10)3158601
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 03/16/2025

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: Other
• Device Catalogue Number: 305541
• Device Lot Number: 3158601
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/23/2025; Not provided
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 01/28/2025; 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown