MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE; HYPODERMIC NEEDLE

Catalog Number	928855
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: n/a.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd¿ insulin syringe was cracked on one side and leaked when drawing up insulin.There was no report of injury or medical interventions.
Additional Manufacturer Narrative
Customer returned one 3/10cc, 8mm, 30g walgreens syringe in an open poly bag with part of the shelf carton from lot # 6347590.Customer states that the syringe was cracked on one side and insulin leaked out when drawing up.The returned syringe was examined and exhibited a piece of the barrel broken off ranging from the 0-11 unit markings.This condition could cause leakage when drawing.As per manufacturing, a review of the device history record was completed for batch # 6347590 all inspections were performed per the applicable operations qc specifications.There was one notification noted that did not pertain to the complaint.Investigation conclusion: based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (broken barrel and leakage).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¿ INSULIN SYRINGE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7334935
• Report Number: 1920898-2018-00119
• Device Sequence Number: 10798084
• Product Code: FMI
• UDI-Device Identifier: 00311917025278
• UDI-Public: 00311917025278
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K955235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: Lay User/Patient
• Device Catalogue Number: 928855
• Device Lot Number: 6347590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/13/2018
• 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