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

Catalog Number	928850
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
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 the hub separated and was in the needle shield with a bd syringe 1.0ml 29ga 1/2in.This occurred on 2 separate occasions prior to use.The following information was provided by the initial reporter: it was reported that 2 syringes the needle hub was in the needle shield off the syringe in the bag.
Additional Manufacturer Narrative
After further information received, it has been determined that the previously submitted mfr report #1920898-2019-01082 was sent in error.The original complaint of hub separating from device was incorrect, the correct issue "product is damaged (broken, missing, unassembled) device is inoperable" is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that the hub separated and was in the needle shield with a bd syringe 1.0ml 29ga 1/2in.This occurred on 2 separate occasions prior to use.The following information was provided by the initial reporter: it was reported that 2 syringes the needle hub was in the needle shield off the syringe in the bag.

• Brand Name: BD SYRINGE 1.0ML 29GA 1/2IN
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9152413
• Report Number: 1920898-2019-01082
• Device Sequence Number: 14133720
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (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): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 928850
• Device Lot Number: 8302707
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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