MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

Catalog Number 320440

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 the bd insulin syringe with the bd ultra-fine¿ needle separated and the needle remained in the skin.An x-ray was performed and the needle was removed from the skin with no surgical intervention required.

Manufacturer Narrative

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 due to unknown lot number for needle break off in use.Severity: s_3__; occurrence: unable to perform complaint lot history check due to unknown lot number for needle break off in use.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.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7280967
• MDR Text Key: 100404718
• Report Number: 1920898-2018-00049
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

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?: No
• Device Operator: Other
• Device Catalogue Number: 320440
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention