MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINEI IV INSULIN SYRINGE; PISTON SYRINGE

Model Number	329424
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.(b)(4).Investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 6123812.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This batch was manufactured before expiration dates were put on packaging.Occurrence: a complaint history check was performed and this is the 1st related complaint for label information missing (expiration date) on lot # 6123812.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, label information missing (expiration date)) was captured and addressed appropriately.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the box of bd micro-finei¿ iv insulin syringes had no expiration date printed on it.This was noticed during use.The following information was provided by the initial reporter: "pharmacist stated she has 5 -6 boxes of the bd insulin syringes, all with the same lot # and catalog # and none of them have expiration dates on them.Stated she provided a consumer with one box of these syringes and the consumer returned it, stating he did not want to use this box because he looked the product up online and he believes they expired in 2016.Advised pharmacist of how bd determines the expiration date using the copyright date, the lot # and julian date.Pharmacist stated there is no copyright/trademark date or manufacture date on any of the boxes.Advised pharmacist that the lot # means this box was either manufactured in 2006 expiring in 2011 or 2016 expiring in 2021.".

• Brand Name: BD MICRO-FINEI IV INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10131056
• Report Number: 1920898-2020-00634
• Device Sequence Number: 2561127
• Product Code: FMF
• UDI-Device Identifier: 30382903294245
• UDI-Public: 30382903294245
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: 329424
• Device Catalogue Number: 329424
• Device Lot Number: 6123812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/08/2020
• 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