MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS MEDICAL DEVICE BRAND NAME; PISTON SYRINGE

Catalog Number 309646

Device Problems Break (1069); Unintended Ejection (1234); Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

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 a bd luer-lok¿ syringe sterile, single use had a broken barrel that leaked and sprayed on the patient and or nurse in the operating room during an emergency case that required rapid sequence induction.The anesthesia provider had to rapidly draw up another dose.No other medical intervention was reported.There was no report of exposure to the mucous membrane.

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.No root cause can be determined as no samples were received.

Event Description

It was reported that a bd luer-lok syringe sterile, single use had a broken barrel that leaked and sprayed on the patient and or nurse in the operating room during an emergency case that required rapid sequence induction.The anesthesia provider had to rapidly draw up another dose.No other medical intervention was reported.There was no report of exposure to the mucous membrane.

• Brand Name: MEDICAL DEVICE BRAND NAME
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7930771
• MDR Text Key: 122636695
• Report Number: 1213809-2018-00683
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 309646
• Device Lot Number: 8155943
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other