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

Model Number	305541
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that there was no expiration date on the syringe allergy 1ml w/ndl 27x3/8 ib packaging.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "consumer reported item # 305541, lot # 6111954 no expiration dates on packages".
Additional Manufacturer Narrative
H.6.Investigation: since no samples (including photos) were returned for the reported issue of ¿no expiration dates on packages¿ with lot number 6111954 regarding item # 305541 the complaint could not be confirmed, and the root cause is undetermined.A review of the device history record was completed for batch# 6111954.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This was manufactured before expiration dates were printed on packaging.H3 other text : see h.10.
Event or Problem Description
It was reported that there was no expiration date on the syringe allergy 1ml w/ndl 27x3/8 ib packaging.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "consumer reported item # 305541, lot # 6111954 no expiration dates on packages.".

• 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
• MDR Report Key: 11175022
• Report Number: 1920898-2021-00062
• Device Sequence Number: 16679375
• Product Code: FMF
• UDI-Device Identifier: 30382903055419
• UDI-Public: 30382903055419
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: 305541
• Device Catalogue Number: 305541
• Device Lot Number: 6111954
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1