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

Model Number	328507
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/07/2020
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 two syringes 0.5ml 29ga 12.7mm experienced molding defects -sharp protrusions.Product defect was noted during use.The following information was provided by the initial reporter: material no: 328507 batch no: unknown (provided 4160830).Consumer reported, he's cutting his finger on flanges located on plunger rod.Stated, flanges are really sharp did not seek medical, administered his own first aid at home stated, it's happened twice.Lot: 4160830, catalog: 328507, date of event: unknown, samples available cl.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned as of 7 may 2020 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 review due to an 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.
Event or Problem Description
It was reported that two syringes 0.5ml 29ga 12.7mm experienced molding defects -sharp protrusions.Product defect was noted during use.The following information was provided by the initial reporter: material no: 328507, batch no: unknown (provided 4160830).Consumer reported, he's cutting his finger on flanges located on plunger rod.Stated, flanges are really sharp did not seek medical, administered his own first aid at home stated, it's happened twice lot: 4160830, catalog: 328507, date of event: unknown, samples available cl.

• Brand Name: SYRINGE 0.5ML 29GA 12.7MM
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10003444
• Report Number: 1920898-2020-00430
• Device Sequence Number: 2897048
• Product Code: FMF
• UDI-Device Identifier: 00681131311649
• UDI-Public: 00681131311649
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/08/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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