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

Catalog Number 309657

Device Problems Bent (1059); Use of Device Problem (1670)

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

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 the plunger on a 3 ml bd luer-lok¿ disposable syringe with bd luer-lok¿ tip ¿was difficult to use, stating the plunger "bends¿ and is ¿very hard to use.¿ there was no report of injury or medical intervention reported.

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.No sample (including photos) were received for evaluation.Batch number is unknown, and no product defect confirmed due to lack of information.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• 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: 7366691
• MDR Text Key: 103539303
• Report Number: 1213809-2018-00139
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/27/2018
• 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