MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL; PISTON SYRINGE

Model Number	328510
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
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: na.The customer's address is (b)(6) has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 0.3ml 29ga 12.7mm 10bag 500 wal was missing the expiration date.The following information was provided by the initial reporter: material no: 328510 batch no: 5180853.It was reported no expiration date on a box of relion syringes.Verbatim: relative of consumer reported no expiration date on a box of relion syringes.Stated the syringes were purchased in 2015 and some were used.Advised that this product box would be expired.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 0.3ml 29ga 12.7mm 10bag 500 wal was missing the expiration date.The following information was provided by the initial reporter: material no: 328510 batch no: 5180853.It was reported no expiration date on a box of relion syringes.Verbatim: relative of consumer reported no expiration date on a box of relion syringes.Stated the syringes were purchased in 2015 and some were used.Advised that this product box would be expired.

• Brand Name: SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11510052
• Report Number: 1920898-2021-00311
• Device Sequence Number: 4047538
• Product Code: FMF
• UDI-Device Identifier: 00681131311663
• UDI-Public: 00681131311663
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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 Model Number: 328510
• Device Catalogue Number: 328510
• Device Lot Number: 5180853
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1