MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSULIN SYRINGE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

]date of event: unknown.The date received by manufacturer has been used for this field.]medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.Device manufacture date: unknown a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified bd insulin syringe had a serious medical impact.No further information could be obtained.The following information was provided by the initial reporter: "it was reported that consumer stated his spouse was going to die.Consumer husband reported to a bd associate at the nassc that his wife was going to die from using the bd products.The bd associate attempted to transfer the caller to bd com but was unsuccessful in doing so.Bd associate was unable to obtain the callers information before transfer.Caller was belligerent and cursive.Lot #: unknown we will not be able to obtain this information.Catalog#: unknown we will not be able to obtain this information.Date of event: unknown we will not be able to obtain this information.Samples status no samples.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform a dhr review due to an unknown lot number.H3 other text : see h.10.

Event Description

It was reported that an unspecified bd insulin syringe had a serious medical impact.No further information could be obtained.The following information was provided by the initial reporter: "it was reported that consumer stated his spouse was going to die.Consumer husband reported to a bd associate at the nassc that his wife was going to die from using the bd products.The bd associate attempted to transfer the caller to bd com but was unsuccessful in doing so.Bd associate was unable to obtain the callers information before transfer.Caller was belligernent and cursive.Lot #: unknown we will not be able to obtain this information catalog#: unknown we will not be able to obtain this information date of event: unknown we will not be able to obtain this information samples status no samples".

• Brand Name: UNSPECIFIED BD INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10171692
• MDR Text Key: 199989798
• Report Number: 2243072-2020-00929
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other