MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD LUER-LOK¿ TIP SYRINGE

Catalog Number 309604

Device Problem Air Leak (1008)

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

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the rubber stopper was twisted on a 10 ml bd luer-lok¿ tip syringe.The syringe was used on a patient's central line and air was introduced into the line because of the alleged defect.When this occurred the initial reporter stated that they immediately got a new syringe and removed the air and the fluid from the line before it got to the patient.There was no reported injury to the patient and no medical interventions were provided.

Manufacturer Narrative

Results: although it was previously reported that a sample would be returned for evaluation, a sample was not returned.A review of the device history record could not be performed as a lot number for this incident was not provided.In the event that new, changed, or corrected information is obtained, another supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to confirm the customer¿s indicated failure mode.

• Brand Name: 10 ML BD LUER-LOK¿ TIP SYRINGE
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5780558
• MDR Text Key: 49832008
• Report Number: 1213809-2016-00024
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309604
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other