H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of holes or splits in the probe covers was confirmed and appears to be supplier related.The products returned for evaluation were two probe cover kits with gel.The kits were received unopened and unused.The kits were labeled with the use by date of 2023-05-31 which had not been exceeded.The probe covers appeared unremarkable to gross visual examination.No holes, cuts, tears, rips, or perforations were visible in the material under gross visual examination.The seams appeared consistent along the length of the devices.The lengths and widths of the returned probe covers met the device specifications.The distal 12¿ of the probe covers were filled with water and observation was conducted, looking for leaks in the seams and/or materials.When sample 1 was tested, a small dripping leak was observed in the distal end, along the crease in the cover.When sample 2 was tested, a spraying leak was observed 2.8¿ from the distal end of the cover.As the devices were unopened prior to being evaluated, the cause is likely related to the materials or manufacturing process.Bd is working closely with manufacturing to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
|