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

Model Number	928852
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2020
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 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 plunger issues occurred during use with a bd¿ insulin syringe with needle.The following information was provided by the initial reporter, "consumer reported plunger rod difficult to move, consumer does not re-use.".
Additional Manufacturer Narrative
H.6.: investigation summary : no samples (including photos) were returned as of (b)(6) 2020 therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st related complaint for plunger rod difficult to move for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) is required at this time.H3 other text : see h.10.
Event or Problem Description
It was reported that plunger issues occurred during use with a bd¿ insulin syringe with needle.The following information was provided by the initial reporter, "consumer reported plunger rod difficult to move, consumer does not re-use.".

• Brand Name: BD INSULIN SYRINGE WITH NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10059890
• Report Number: 1920898-2020-00522
• Device Sequence Number: 11686611
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• 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): 06/05/2020

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 Expiration Date: 12/31/2021
• Device Model Number: 928852
• Device Catalogue Number: 928852
• Device Lot Number: 6347588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/05/2020
• 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