MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29G X 1/2 IN ATTACHED NEEDLE; INSULIN SYRINGE AND NEEDLE

Catalog Number	305930
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
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.
Event or Problem Description
It was reported that a 1 ml bd safetyglide¿ insulin syringe with 29g x 1/2 in attached needle had a melted plug.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) 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# 7296899.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200729957, 200731263] noted that did not pertain to the complaint.Based on the samples / photo(s) 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.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that a 1 ml bd safetyglide¿ insulin syringe with 29g x 1/2 in attached needle had a melted plug.

• Brand Name: 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29G X 1/2 IN ATTACHED NEEDLE
• Common Device Name: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8135542
• Report Number: 1920898-2018-00919
• Device Sequence Number: 19224808
• Product Code: MEG
• UDI-Device Identifier: 00382903059300
• UDI-Public: 382903059300
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 11/30/2022
• Device Catalogue Number: 305930
• Device Lot Number: 7296899
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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