MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH SYRINGE 10ML SALINE XS; SALINE FLUSH SYRINGE

Catalog Number 306572

Device Problem Illegible Information (4050)

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

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Investigation summary: a device history record review was performed for provided lot number 9163585 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To further investigate this issue, one picture sample was provided for evaluation by our quality engineer team.Through examination of the picture, the lot number was observed illegible on the product packaging.During the label printing process, the print may drift outside of the designated print window.An adjustment has been made to the printing machine to bring it back into alignment.Any affected product should have been detected by the vision inspection system and contained prior to release, however, an error in the vision system occurred.A new vision system has been installed and validated to inspect 100% of variable printing issues.Our quality team will continue to monitor the production process for signs of this defect and other emerging trends.Investigation conclusion: batch code: 9163585.The non-conformance's were reviewed for this batch, and there was no record of non-conformance associated with this complaint.Conclusion(s): the returned photo confirmed illegible batch number print.Based on the investigation, the root cause of this defect may be related to an issue with the vision system on the machine.The print can drift in the variable print window area.In this occurrence it drifted outside the variable print window and impinged on the fixed pre-printed graphics.An adjustment was made to the machine at the time of occurrence to bring it back into alignment, however, not all affected product was sufficiently contained.A new vision system subsequently installed and validated which 100% inspects for variable print and this issue has not occurred since.Root cause description: based on the investigation, the root cause of this defect may be related to an issue with the vision system on the machine.

Event Description

It was reported that 240 bd posiflush syringe 10ml saline xs were found with illegible batch numbers on the unit packaging.

• Brand Name: BD POSIFLUSH SYRINGE 10ML SALINE XS
• Type of Device: SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9718038
• MDR Text Key: 194491658
• Report Number: 9616657-2020-00027
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9163585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• 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