MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB; PISTON SYRINGE

Catalog Number	305946
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 sftygld 1ml w/ndl 26x3/8 ib had a safety failure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 305946, batch no.: 8087774.It was reported that the bevel does not line up with the safety mechanism and it is not its usual color.The bevel does not line up with the safety.In the past, the bevel always lined up with the safety so you know where the bevel is to insert the intradermal injection.When it is not lined up, it makes it extremely difficult to find the bevel and insert.305946 - why doesn't the bevel line up with the safety? and aren't they usually orange?.
Additional Manufacturer Narrative
Investigation: customer returned a photo of a 1cc bd safetyglide insulin syringe.Customer states that the bevel does not line up with the safety mechanism and it is not its usual color.The attached photo was examined and no defects were observed regarding the coloring of the sample.Also, no defects were observed on the cannula of the syringe.During production, the needle is not oriented in any specific way in relation to the safety mechanism and there is no specification regarding this.A review of the device history record was completed for batch# 8087774.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200777379, 200777012] noted that did not pertain to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that syringe sftygld 1ml w/ndl 26x3/8 ib had a safety failure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 305946 batch no.: 8087774.It was reported that the bevel does not line up with the safety mechanism and it is not its usual color.The bevel does not line up with the safety.In the past, the bevel always lined up with the safety so you know where the bevel is to insert the intradermal injection.When it is not lined up, it makes it extremely difficult to find the bevel and insert.305946 - why doesn't the bevel line up with the safety? and aren't they usually orange?.

• Brand Name: SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8518434
• Report Number: 1920898-2019-00353
• Device Sequence Number: 1303608
• Product Code: MEG
• UDI-Device Identifier: 30382903059462
• UDI-Public: 30382903059462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 305946
• Device Lot Number: 8087774
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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