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

Model Number 328507

Device Problem Leak/Splash (1354)

Patient Problem Laceration(s) (1946)

Event Date 04/07/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10003444
• MDR Text Key: 196797815
• Report Number: 1920898-2020-00430
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311649
• UDI-Public: 00681131311649
• Combination Product (y/n): N
• PMA/PMN Number: K941657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 328507
• Device Catalogue Number: 328507
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other