Catalog Number 304134 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that "burrs" were found on the white plastic part of the syringe control 10ml ll bns before use.This complaint was created to capture the first of two related incidents.The following information was provided by the initial reporter: "burrs and blotching on the white plastic part of the syringe" mcl# 3647 (bd part 304134) has multiple lots with nonconformities on the plastics, specifically flashing and burrs.
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Event Description
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It was reported that "burrs" were found on the white plastic part of the syringe control 10ml ll bns before use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "burrs and blotching on the white plastic part of the syringe".Mcl# 3647 (bd part 304134) has multiple lots with nonconformities on the plastics ¿ specifically flashing and burrs.
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Manufacturer Narrative
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Investigation summary: two photos were received and evaluated.The photos depict finger grips and thumb grip of two 10ml control syringes from unidentified batches.Deformations in the white plastic where it comes in contact with the clear plastic of the barrels were observed.The deformations have the appearance of melting or flash and are located near the weld points.Dhr review for batch #8270914: release date: 10/22/2018.Released quantity was (b)(4).All visual inspections were performed as per requirement.A quality notification was issued for weld issues during the manufacture of this batch.Production was stopped, adjustments were made and product requalified per applicable aql before production resumed.Batch 8270914 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Potential root cause for the flash observed is likely a result of a temporary issue with the welding process.However, a physical sample is required for evaluation and to confirm potential root cause determination.Corrections took place at the time the defects were found in production, including machine adjustments and product requalification per aql.It is possible a limited number of pieces with the observed defect escaped detection.The aql for plastic protruding from the weld area is (b)(4).Defective rate identified is 2 out of batch size (b)(4), which is (b)(4).No additional actions are necessary at this time.Batches 8270914 and 8323971 are considered in compliance with our product specification requirements.Controls are in place which include periodic visual product inspections to ensure containment of defects and overall product quality.
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Search Alerts/Recalls
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