MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928858
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 40 syringes 0.3ml 31ga 8mm 10bag 500 pl/wg had issues with the needle hub separating into the cap when removing it.This complaint was created to capture the 11th of 14 related incidents.The following information was provided by the initial reporter: "rep reported about 40 syringes in consumer's box had an issue.Stated when removing the orange cap the whole needle component came off with the cap.Rep is reporting of behalf of consumer.".
Additional Manufacturer Narrative
H.6.Investigation: 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 # 9324122 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200865195] noted that did not pertain to the complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that 40 syringes 0.3ml 31ga 8mm 10bag 500 pl/wg had issues with the needle hub separating into the cap when removing it.This complaint was created to capture the 11th of 14 related incidents.The following information was provided by the initial reporter: "rep reported about 40 syringes in consumer's box had an issue.Stated when removing the orange cap the whole needle component came off with the cap.Rep is reporting of behalf of consumer.".

• Brand Name: SYRINGE 0.3ML 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: 11051536
• Report Number: 1920898-2020-01726
• Device Sequence Number: 11433942
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 12/31/2024
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 9324122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1