MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; SYRINGE AND NEEDLE

Catalog Number 324909

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle had foreign matter or "moisture" in the syringe.No serious injury or medical intervention reported.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: male.Event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle had foreign matter or "moisture" in the syringe.No serious injury or medical intervention reported.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle had foreign matter or "moisture" in the syringe.No serious injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch # 7268719 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for foreign matter on lot # 7268719.Based on the samples / photo(s) 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.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.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7724831
• MDR Text Key: 115361069
• Report Number: 1920898-2018-00553
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: 00382903249091
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324909
• Device Lot Number: 7268719
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other