MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE

Catalog Number	305934
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
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 bd safetyglide¿ insulin syringe had a cracked and broken barrel.There was no report of exposure, serious injury, or medical intervention.
Event or Problem Description
It was reported that a bd safetyglide¿ insulin syringe had a cracked and broken barrel.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
Investigation summary: customer returned (1) 1/2cc, 8mm, 30g bd safetyglide insulin syringe in an open poly bag from lot#: 7167887.Customer states that the syringe is damaged.The returned syringe was examined and exhibited a piece of the barrel broken off of the sample ranging from the 40 unit marking to the flange.A review of the device history record was completed for batch#: 7167887.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200705294, 200705293] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Probable root cause was noted to be the barrel likely being broken in the prep dial prior to assembly, which accounts for the lack of damage to the needle assembly.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8026185
• Report Number: 1920898-2018-00837
• Device Sequence Number: 11173523
• Product Code: FMF
• UDI-Device Identifier: 00382903059348
• UDI-Public: 382903059348
• 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): 11/27/2018

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: 07/31/2022
• Device Catalogue Number: 305934
• Device Lot Number: 7167887
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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