TRIPATH IMAGING, INC VIAL SUREPATH COLLECTION KIT 500; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
|
Back to Search Results |
|
Catalog Number 491452 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/21/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E1: initial reporter address 1: (b)(6).H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
Report 4 of 8.It was reported that while using vial surepath collection kit 500, there was a cracked vial containing patient sample.No patient impact reported.The following information was provided by the initial reporter: "cracked caps on vials: i attach evidence of 8 vials that arrived with broken caps, before having been processed by the multiprocessor instruments.8 vials from lot 2300761.Are each of the 8 vials samples from different patients? yes was there any impact on patient samples for diagnostic testing? yes did the patients' samples have to be taken again? yes if patients were re-sampled, were there any changes or delays in treatment? we are waiting for them to come to take the new sample.".
|
|
Event Description
|
Report 4 of 8.It was reported that while using vial surepath collection kit 500, there was a cracked vial containing patient sample.No patient impact reported.The following information was provided by the initial reporter: "cracked caps on vials - i attach evidence of 8 vials that arrived with broken caps, before having been processed by the multiprocessor instruments.8 vials from lot 2300761.Are each of the 8 vials samples from different patients? yes.Was there any impact on patient samples for diagnostic testing? yes.Did the patients' samples have to be taken again? yes.If patients were re-sampled, were there any changes or delays in treatment? we are waiting for them to come to take the new sample.".
|
|
Manufacturer Narrative
|
H6.Investigation summary: the customer complaint is for vials with broken caps for material 491452 lot number 2300761.The investigation consisted of a review of the device history records from production, retain analysis, customer return analysis and related customer complaint trending.The review of the manufacturing batch records for material 491452 lot 2300761 identified that it was complete and accurate with no indication of any issues or abnormal activities during the production of the lot.There were zero defects observed during the inspection of the caps used in the production of material 491452 lot 2300761.A visual retain analysis was performed on one clamshell (25 vials) from item 491452 lot 2300761.The complaint mode was not identified during retain analysis.A returned sample was not available so no formal inspection could be performed.However, pictures were provided that show the cracked cap.Therefore, the complaint is confirmed.A 12-month complaint review for the defect mode of cracked cap and empty vial was performed and identified previous complaints for the item number but no previous complaints for the lot number.
|
|
Search Alerts/Recalls
|
|
|