Catalog Number 305210 |
Device Problems
Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/27/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medical device expiration date: n/a.(b)(6).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 the ink was coming off bd¿ oral dispensing syringe 3 ml.Also felt like lubrication was on the syringe.
|
|
Event Description
|
It was reported the ink was coming off bd¿ oral dispensing syringe 3 ml.Also felt like lubrication was on the syringe.
|
|
Manufacturer Narrative
|
Investigation: 34 loose 1ml amber oral syringes were received inside an opened bag from batch #8263592 (p/n 305210).They were visually evaluated.Most of the syringes were observed to have missing print defect in the area between 1ml and zero line.The amount of print missing was rejectable per product specification.Missing print was found during production and adjustments were made to address the issue.Potential root cause for the missing print defect is associated with the marking process.Corrections took place at the time the defect was found during production.All visual inspections were performed as per requirement.A quality notification was issued for missing print during the manufacture of this batch.Adjustments were made and product requalified per applicable aql before production resumed.Batch 8263592 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.
|
|
Search Alerts/Recalls
|