MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10ML BD LUER-LOK¿ SYRINGE, 20GX1" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 309644

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

Patient Problem Death (1802)

Event Date 07/27/2016

Event Type  Death  

Manufacturer Narrative

Date of event; date of death: the date of event is unknown therefore the date received by the manufacturer is used.The patient was reported to have passed away over a year ago.The medical device expiration date is unknown as the lot number is unknown.The device manufacture date is unknown as the lot number is unknown.Device evaluation: investigation summary - no samples were returned, or a lot number provided therefore the complaint could not be confirmed and the root cause is undetermined.In the verbatim it refers to a recall of the 10ml luer lok 20 gauge syringe of catalog number 309644.A product advisory was initiated for insecure stoppers.Refer to mss-14-485-sa.Potential issue for insecure stopper is leakage pass the stopper.For this issue, it is highly unlikely that the device in question lead to the patient¿s unfortunate death.The investigation concluded - bd was not able to duplicate or confirm the customer¿s indicated failure.

Event Description

A report was received from the customer with the following verbatim: "when performing effectiveness check on a supplier recall for the bd 10cc syringe luer lok 20gx1 detachable, a woman answered the phone.When i asked to speak with [the customer], she informed me he passed away over a year ago." no additional information was received and the relationship of the suspect device to the patient death is unknown.

• Brand Name: 10ML BD LUER-LOK¿ SYRINGE, 20GX1" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5876454
• MDR Text Key: 52110151
• Report Number: 1213809-2016-00026
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2016

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: 309644
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/15/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death