MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/21/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 0.5ml 31ga 8mm 10bag 500 pl/wg hub and needle were stuck inside the shield.This was discovered before use.The following information was provided by the initial reporter: material no: 928857 batch no: 9168527.It was reported that the customer was one syringe short and also the hub and needle were stuck inside shield.Verbatim: consumer reported finding one bag with only 9 syringes instead of 10.Stated, the bag was sealed.Stated, when she removed shield from syringe, the hub and needle are now stuck inside shield.
Event or Problem Description
It was reported that syringe 0.5ml 31ga 8mm 10bag 500 pl/wg hub and needle were stuck inside the shield.This was discovered before use.The following information was provided by the initial reporter: material no: 928857 batch no: 9168527.It was reported that the customer was one syringe short and also the hub and needle were stuck inside shield.Verbatim: consumer reported finding one bag with only 9 syringes instead of 10.Stated, the bag was sealed.Stated, when she removed shield from syringe, the hub and needle are now stuck inside shield.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) 1/2cc, 8mm, 31g walgreens syringe in an open poly bag from lot # 9168527.Customer states that they are finding one bag with only 9 syringes instead of 10 and the hub and needle are now stuck inside shield.The syringe was returned with the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch# 9168527.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.- confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates) - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (short count in poly bag) as the poly bag was returned opened process summary: automatic syringe assembly machine, which feeds 0.5ml syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Root cause: there was debris in the dial.Corrective action: l2l dispatch #70904 to clean debris out of the dial.

• Brand Name: SYRINGE 0.5ML 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: 9831890
• Report Number: 1920898-2020-00248
• Device Sequence Number: 10951162
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 03/26/2020

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: 06/30/2024
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 9168527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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