MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB; PISTON SYRINGE

Model Number	305500
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: the product was manufactured prior to the inclusion of expiration dates on the device packaging.Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for label information missing (expiration date) on lot # 7037942.Investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch #7037942.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This batch was manufactured before expiration date was on packaging.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that many syringe allergy 1ml w/ndl 28x1/2 rb boxes were missing an expiration date.The following information was provided by the initial reporter: "pharmacist reported many item #s and lot #s.The boxes are missing exp dates.Catalog # 305500 one box with lot # 7037942.".

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10040332
• Report Number: 1920898-2020-00493
• Device Sequence Number: 2782771
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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 Model Number: 305500
• Device Catalogue Number: 305500
• Device Lot Number: 7037942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other