MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928856
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that a syringe 1.0ml 31ga 8mm 10bag 500 pl/wg had missing scale markings before use.The following was reported by the initial reporter: "it was reported that the scale print was missing on one syringe.Verbatim: voicemail : consumer left voicemail stating that the scale print is missing on one syringe.01-14-21: i returned consumer's call, he stated that the scale print is missing on one syringe, he also stated that the bag was sealed.".
Event or Problem Description
It was reported that a syringe 1.0ml 31ga 8mm 10bag 500 pl/wg had missing scale markings before use.The following was reported by the initial reporter: "it was reported that the scale print was missing on one syringe.Verbatim: voicemail : consumer left voicemail stating that the scale print is missing on one syringe.01-14-21: i returned consumer's call, he stated that the scale print is missing on one syringe, he also stated that the bag was sealed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-09.Investigation summary: customer returned (1) 1cc, 8mm, 31g (b)(4) syringe in an open poly bag from lot # 0027932.Customer states that the scale print was missing on one syringe.The returned syringe was examined and exhibited missing scale print on the barrel.A review of the device history record was completed for batch# 0027932.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11291209
• Report Number: 1920898-2021-00162
• Device Sequence Number: 11832200
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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 Expiration Date: 02/28/2025
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: 0027932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 04/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1