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

Catalog Number	305620
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 305620.Batch #: unknown.It was reported that the bd syringe 1/2ml w/ndl 27x1/2 rb had foreign matter.The following information was provided by the initial reporter: my customer sent me these pictures and wants to know if the manufacturer can explain the liquids he found in 50 needles looking at the pictures i couldn¿t tell he said it¿s not a complaint¿ please see below for his comments.I got an issue about item #: bd-305620 which i have ordered many times.Please find files and share with manufacturer.Since the syringes are individually packaged, it is unlikely that liquid entered them during the distribution process it was reported in 50 ea.It is not a complaint, but just curious.You can see liquid in the needles.Liquid like water come out from part of the syringe.It was reported in 50 each.It is not a complaint, but just curious why it happens.
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: 2 photos were received and analyzed by our quality team.The photos verify a substance but this is most likely the medical grade silicone lubricant that is used to assemble syringes and ensure that they work properly.The root cause is unknown though without a physical sample for investigation.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
Photo received.

• Brand Name: BD SYRINGE 1/2ML W/NDL 27X1/2 RB
• 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: 19550345
• Report Number: 1920898-2024-00131
• Device Sequence Number: 6710961
• Product Code: FMF
• UDI-Device Identifier: 00382903056200
• UDI-Public: (01)00382903056200
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 11/19/2024

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: 305620
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown