MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Catalog Number 302995

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Discomfort (2330)

Event Date 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd luer-lok¿ syringe sterile, single use leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: incident details: patient was being intubated and the bedside nurse had attached a 10cc syringe of rocuronium to the patients central line.The nurse pushed the medication and immediately got sprayed in the face with the medication.Nurse left the room and writer went in to finish the intubation.Writer pushed on syringe and also got sprayed in the face with the medication.First aid provided to myself and other nurse (eye wash).Upon closer inspection of the syringe with rocuronium, a crack in the syringe is noted from the 4ml to 9ml marking, and sucked in air when writer tried to draw up saline.The nurse who prepared the syringe stated she had no difficulty drawing up medication.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 29-aug-2023.H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the barrel had a vertical crack extending from 2.8ml to 9ml grad lines.The observed condition is non-conforming per product specification.Potential root cause for the cracked barrel and leakage defects are associated with the assembly process.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) and corrective action determination could not be performed.

Event Description

It was reported while using bd luer-lok¿ syringe sterile, single use leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: incident details: patient was being intubated and the bedside nurse had attached a 10cc syringe of rocuronium to the patients central line.The nurse pushed the medication and immediately got sprayed in the face with the medication.Nurse left the room and writer went in to finish the intubation.Writer pushed on syringe and also got sprayed in the face with the medication.First aid provided to myself and other nurse (eye wash).Upon closer inspection of the syringe with rocuronium, a crack in the syringe is noted from the 4ml to 9ml marking, and sucked in air when writer tried to draw up saline.The nurse who prepared the syringe stated she had no difficulty drawing up medication.

• Brand Name: BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
• Type of Device: PISTON SYRINGE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17604946
• MDR Text Key: 321763094
• Report Number: 1213809-2023-00894
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302995
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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