Catalog Number 1884 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Potential lot numbers reported: 74a1602818, 74a1603215, 74b1602277 and 74c1600209.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo for review.The device history record of (b)(4) that belong to catalog number 1884 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.However material from the production line was inspected and no issues were detected that can lead this customer complaint.If device sample becomes available at a later date this complaint will be re-opened.
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Event Description
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The customer alleges the nebulizer kit separated at the universal tubing end of the tubing.It popped off when attached to the flow meter.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the connector was separated from the tubing.It was also found that the tubing contained pip residue.A dimensional inspection was performed and the internal diameter of the universal connector and the external diameter of tubing were found to be within specification.Based on the investigation performed, the reported complaint was confirmed.The disconnection of the connector and the tubing could be caused by an incorrect assembly of the tubing and the connector; therefore , all personnel from the production line were re-trained on the work instruction.In addition, a non-conformance was generated.
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Event Description
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The customer alleges the nebulizer kit separated at the universal tubing end of the tubing.It popped off when attached to the flow meter.
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Search Alerts/Recalls
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