MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE W/ BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Catalog Number 328418

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: level a investigation complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: unable to perform complaint lot history check for flange damaged and harm due to unknown lot number.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check for flange damaged and harm due to unknown lot number.Investigation conclusion: 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.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 bd insulin syringe w/ bd ultra-fine¿ needle had molding defects.This was discovered during use.The following information was provided by the initial reporter: material no: 328418, batch no: unknown.It was reported by the consumer that the flanges are not smooth and hurts when pulling on the plunger rod.Consumer reported when she pulls on plunger rod, the "flanges" are not smooth and she hurts her fingers.Stated, bd should make "flanges" smoother.Stated, she re-uses because she can't afford them.Did not seek medical.Incident date unknown.Stated, some friends of hers experienced the same issue, "someone almost loss a finger from cutting themselves." on flanges located on plunger rod.Does not have samples to send back.

• Brand Name: BD INSULIN SYRINGE W/ BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8945636
• MDR Text Key: 156033352
• Report Number: 1920898-2019-00887
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328418
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other