MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 12.7MM 10BAG; PISTON SYRINGE

Model Number	328507
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 7 syringe 0.5ml 29ga 12.7mm 10 bag experienced the cannula breaking off or pulling out during use.The following information was provided by the initial reporter: material no: 328507, batch no: 7261941.Verbatim: daughter called on behalf of her mother.Stated, needles are breaking in half when injecting into vial, to draw up medicine.7 syringes affected and not able to use for injection.Does not re-use.Discarded samples.Lot: 7261941.Item: 29g, 12.7, 1ml.
Additional Manufacturer Narrative
H.6.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 dhr check for needle breaks off in vial due to unknown lot number.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.H3 other text : see section h.10.
Event or Problem Description
It was reported that 7 syringe 0.5ml 29ga 12.7mm 10bag experienced the cannula breaking off or pulling out during use.The following information was provided by the initial reporter: material no: 328507; batch no: 7261941.Verbatim: daughter called on behalf of her mother.Stated, needles are breaking in half when injecting into vial, to draw up medicine.7 syringes affected and not able to use for injection.Does not re-use discarded samples.Lot: 7261941; item: 29g, 12.7, 1ml.

• Brand Name: SYRINGE 0.5ML 29GA 12.7MM 10BAG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9547606
• Report Number: 1920898-2019-01523
• Device Sequence Number: 2535895
• Product Code: FMF
• UDI-Device Identifier: 00681131311649
• UDI-Public: 00681131311649
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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 Model Number: 328507
• Device Catalogue Number: 328507
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/17/2020
• 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