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

Model Number	928853
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported 2 bd¿ insulin syringes were missing the expiration date on the packaging.The following information was provided by the initial reporter: "consumer reported not seeing the exp date on this box and bags.
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 22-jun-2022.Investigation summary: customer returned a single syringe in a polybag labeled for 1ml, 30 gauge, 8mm syringe from lot 0168471.The syringe was inspected and measured to ensure that using it was as least harmful as intended.The outer diameter the syringe needle was measured to be 0.0124 in, which is within acceptable outer diameters for 30 gauge needles (0.0120 in to 0.0125 in).An unopened polybag for 1ml, 30 gauge, 8mm syringes from lot 7331982 was also returned.No defects were observed with these syringes and associated polybag.Additionally, no shelf carton was returned for inspection with these samples.No syringes, polybags, or shelf cartons from lot 8071585 were returned.A review of the device history record was completed for batch# 8071585.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Expiration dates were not printed on packaging until 08nov2019.Embecta was unable to confirm the customer¿s indicated failure of label info missing as the samples received were not from the lot in question.Per manufacturing, dates not printed on polybags until nov, 2019.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
Event or Problem Description
It was reported 2 bd¿ insulin syringes were missing the expiration date on the packaging.The following information was provided by the initial reporter: "consumer reported not seeing the exp date on this box and bags.

• Brand Name: BD¿ INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14219192
• Report Number: 1920898-2022-00289
• Device Sequence Number: 17196853
• Product Code: FMF
• UDI-Device Identifier: 00311917025292
• UDI-Public: 00311917025292
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 928853
• Device Catalogue Number: 928853
• Device Lot Number: 8071585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown