A1: patient identifier: requested, not provided.A2: age or date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: n/a.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: phone number: requested, unknown.E3: occupation: combo analyst iii, product quality vigilance.The actual device was not available for evaluation therefore; the details of the actual condition of the sample in unable to be determined.Retention samples were visually inspected and confirmed free from any tilted cannula, bent cannula, or damage to the cannula that might lead to the complaint.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.Prior to the supply of cannula (raw material) to the needle assembly process, qc conducts incoming inspection which includes dimensional inspection and verification of certificate of analysis according to material specification.A total of ten (10) complaints were received from the previous two fiscal years to the present for the same issue where the cause was not identified related to our product and production process.Retention samples were subjected to simulation.The syringe with the safety needle was punctured into the rubber cork.A manual cannula bending test was conducted wherein the needle was bent 45° from left to right forty (40) times.Result, the needle did not break even after 40x bending.The root cause of the complaint could not be identified to be related to our product or manufacturing process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot and the retention samples met the required specifications.Our cannula is supplied with raw material that complies with iso 9626, particularly on stiffness and breakage.The retention samples were confirmed visually in good condition.Simulations were conducted on the samples wherein the needle did not break even after 40x bending which indicates that our needles have high resistance to breakage.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).
|