(b)(4).
No lot number was provided.
A device history record review was performed based upon a lot number from sales history data.
A device history record review was performed on the lor syringe with no relevant findings.
The customer reported more resistance is felt when inserting the plunger into the barrel of an lor syringe.
The customer returned one glass 5ml lor syringe (reference attached files (b)(4)).
The returned lor syringe was visually examined with and without magnification.
Visual examination of the returned syringe appears typical with no defects or anomalies observed.
Prior to decontamination, an attempt was made to slide the syringe plunger inside the barrel.
The returned syringe plunger would not slide.
After decontamination of the returned syringe, an attempt once again to slide the syringe plunger inside the barrel was performed.
The syringe plunger will slide in and out of the barrel with little resistance met.
The movement in the syringe barrel feels typical.
The returned syringe was functionally tested per pip-191 plunger movement test.
A neoprene sleeve was placed on the plunger to prevent breakage and the plunger was retracted out of the barrel to the 5ml marker.
The plunger was then released.
The plunger fell freely to the bottom of the syringe barrel.
The test was repeated twice, rotating the plunger 90 and 180 degrees.
The plunger was able to freely fall each time.
There were no functional issues found.
A corrective action is not required at this time as there were no functional issues found with the returned lor syringe.
The reported complaint of the syringe feels to have more resistance than normal could not be confirmed based on the sample received.
The returned syringe performed typically and the syringe passed the plunger movement test per pip-191.
There were no functional issues found with the returned syringe.
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