MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG; 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	02/11/2019
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 and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg that medication does not stay in syringe and pours back into vial.There were 10 syringes affected.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Unable to perform a dhr due to unknown lot number.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that during use of the syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg that medication does not stay in syringe and pours back into vial.There were 10 syringes affected.
Additional Manufacturer Narrative
Investigation: customer returned (13) loose 29g, 12.7mm, 1ml bd insulin syringes.Customer states when she draws her medication, it does not stay in vile; it pours back into vile.All returned syringes were examined and tested for flow, and all returned syringes passed, therefore the alleged defect could not be confirmed.A review of the device history record was completed for batch# 8057939.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200746676] noted that did not pertain to the complaint.There was one (1) notification [200746210] noted for smeared stoppers.Bd was not able to duplicate or confirm the customer¿s indicated failures.
Event or Problem Description
It was reported that during use of the syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg that medication does not stay in syringe and pours back into vial.There were 10 syringes affected.

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN 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: 8391156
• Report Number: 1920898-2019-00224
• Device Sequence Number: 13512958
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 03/19/2019

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 Catalogue Number: 928850
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 02/11/2019; 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/13/2019; 03/19/2019
• 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