MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE; PISTON SYRINGE

Model Number	928853
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 during use the bd¿ insulin syringe the plunger rod was difficult to move.The following information was provided by the initial reporter: the customer "reported plunger rod difficult to move.".
Event or Problem Description
It was reported during use the bd¿ insulin syringe the plunger rod was difficult to move.The following information was provided by the initial reporter: the customer "reported plunger rod difficult to move.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned as of 4 september 2020 therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform a dhr review for plunger rod difficult to move due to unknown lot number.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.H3 other text : see h.10.

• Brand Name: BD INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10399119
• Report Number: 1920898-2020-01043
• Device Sequence Number: 2743754
• Product Code: FMF
• UDI-Device Identifier: 00311917025292
• UDI-Public: 00311917025292
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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 Model Number: 928853
• Device Catalogue Number: 928853
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/04/2020
• 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