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Model Number 598943P |
Device Problems
Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A review of the manufacturing documentation associated with lot 17850141 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
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Event Description
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As reported, particles (suspect tiny cardboard fragments) were found inside sterile pouch of 9f.098 straight (str) 55cm vista brite tip guiding catheters.Sixteen (16) boxes were affected.These recent units (16 in total) were not involved in any procedure.They were discovered during inspection at the warehouse level.They were not even opened.There was no reported patient injury.The devices will be returned for analysis.
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Manufacturer Narrative
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This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.This report is related to the following reports: 9616099-2020-03962, 9616099-2020-03963, 9616099-2020-03964, 9616099-2020-03965, 9616099-2020-03966, 9616099-2020-03967, 9616099-2020-03968, 9616099-2020-03971, 9616099-2020-03972, 9616099-2020-03973, 9616099-2020-03974, 9616099-2020-03975, 9616099-2020-03976, 9616099-2020-03977 & 9616099-2020-03978.
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Manufacturer Narrative
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This report is related to the following reports: 9616099-2020-03962, 9616099-2020-03963, 9616099-2020-03964, 9616099-2020-03965, 9616099-2020-03966, 9616099-2020-03967, 9616099-2020-03968, 9616099-2020-03971, 9616099-2020-03972, 9616099-2020-03973, 9616099-2020-03974, 9616099-2020-03975, 9616099-2020-03976, 9616099-2020-03977, 9616099-2020-03978.As reported, particles (suspect tiny cardboard fragments) were found inside sterile pouch of 9f.098 straight (str) 55cm vista brite tip (vbt) guiding catheters.Sixteen (16) boxes were affected.These recent units (16 in total) were not involved in any procedure.They were discovered during inspection at the warehouse level.They were not even opened.There was no reported patient injury.Three pictures were initially received for analysis and later sixteen devices were received for analysis.Per picture analysis, the complaint could not be properly evaluated at the time due to the product was not received to proceed with a complete evaluation.Recently, sixteen sterile vbt guide catheters (gc 9f.098 str 55cm) with the outer boxes and inner pouch packaging were received for analysis.Per visual analysis of the received units, the sterility of the pouches was confirmed.The units were received perfectly sealed.However, stains were observed on the mounting cards inside the sealed pouches of the 16 units.Per pet analysis, it was concluded that the contamination detected in the mounting card is not confirmed.Per our procedures, up to three no larger than 0.050¿ inclusions/stains per card are allowed.The number of stains does not exceed three (3), and the stains identified do not measure above 0.050.¿ the units were randomly numbered/ identified from unit one to unit sixteen to perform the analysis.2020-00127334-8 per visual analysis, two stains were observed and measured at <.020" which is considered acceptable per the procedure.A product history record (phr) review of lot 17850141 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿packaging/pouch/box-foreign material - in sterile package¿ was confirmed for all sixteen devices due to the stains observed on the received units.However, per investigation results and after measuring the stains, it was concluded that the units were acceptable according to the procedure.According to the safety information in the instructions for use ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.¿ ¿warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ users are trained to inspect for signs of damage prior to and during use.Any product with damage or sterility concerns is not to be used, as was done in this case.Therefore, the potential for patient injury/death occurring as a result of the observed stains is remote.Neither the phr review nor the product analyses suggest that the event could be related to the manufacturing process of the units.Therefore, no corrective or preventive actions will be taken at this time.
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Search Alerts/Recalls
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