MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD¿ INSULIN SYRINGE/NEEDLE; INSULIN SYRINGE WITH NEEDLE

Catalog Number UNKNOWN

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review was not conducted because a lot number could not be determined.Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.

Event Description

It was reported that the needle of an unknown bd¿ insulin syringe/needle detached and remained in the patients skin.There was no report of medical intervention.

Manufacturer Narrative

Additional information, the original mdr used the bd awareness date (b)(6) 2017 as the date of event, since it was unknown.The date of event is now known.Date of event: (b)(6) 2017.

• Brand Name: UNKNOWN BD¿ INSULIN SYRINGE/NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7161749
• MDR Text Key: 96465379
• Report Number: 2243072-2017-00420
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 02/05/2018
• 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