MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928850
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg experienced difficult aspiration, and difficult plunger rod movement.The following information was provided by the initial reporter: i returned consumer's call.Consumer stated that the plunger rod is difficult to move.Consumer also stated that the needle is crooked/bent.Consumer does not re-use.
Event or Problem Description
It was reported that syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg experienced difficult aspiration, and difficult plunger rod movement.The following information was provided by the initial reporter: i returned consumer's call.Consumer stated that the plunger rod is difficult to move.Consumer also stated that the needle is crooked/bent.Consumer does not re-use.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) 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# 1018509.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h10.

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN 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: 12340075
• Report Number: 1920898-2021-00907
• Device Sequence Number: 4980232
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 02/28/2026
• Device Model Number: 928850
• Device Catalogue Number: 928850
• Device Lot Number: 1018509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1