TELEFLEX MEDICAL HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M W/E; ANESTHESIA BREATHING CIRCUIT
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Catalog Number 311403 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/15/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Five pictures of catalog number 311403 were received for analysis.They were visually inspected but the pictures are not clear enough to identify any issue that can lead to this defect.It is necessary to have the sample to perform an investigation.The device history record of batch number 74l1402124 that belongs to catalog number 311403 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.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed based only on the information provided, the pictures are not clear enough to identify any issue that can lead to this defect.However, 13 samples of current production p/n 311403 (breath circ, anes,adult,exp 0.5-1.8m w/ex) were reviewed and inspected for cracks in the extension tube and no issues were found that can lead to the condition reported by the customer.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 that during pre-testing a crack was found in the system and an air leak was present.No patient injury reported.
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Manufacturer Narrative
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(b)(4).One unit of catalog number 311403 (breath circ, anes, adult, exp 0.5-1.8m w/ex) was received for analysis.It was visually inspected and a "short shot" was found on the extension tube.What the customer is reporting as a "crack in the extension tube" is actually a "short shot".Functional testing was performed on the circuit and the sample passed the test.Leak testing was also performed on the extension tube.The sample failed the leak test due to the "short shot" on the corrugated tube.As an additional test, the extension tube of the sample was immersed under water to identify where the leak came from.It was observed that the leak came from the "short shot" on the corrugated tubing.Based on the investigation performed, the reported complaint was confirmed.A short shot was found on the extension tube.A root cause could not be identified at this time.(b)(4) has been issued to address this problem.
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Event Description
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The customer alleges that during pre-testing a crack was found in the system and an air leak was present.No patient injury reported.
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