MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number 309575

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/15/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion: based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.

Event Description

It was reported that insulin was "exploding" out of the bd luer-lok¿ syringe with bd precisionglide¿ needle during injection.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that insulin was "exploding" out of the bd luer-lok¿ syringe with bd precisionglide¿ needle during injection.There was no report of exposure, injury, or medical intervention noted.

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.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7751761
• MDR Text Key: 116391332
• Report Number: 1213809-2018-00501
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: 30382903095750
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 309575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other