|
The following batches were provided as possible batches used in patient testing and were investigated: d4.Medical device expiration date: 2026-03-03 h4.Device manufacture date: 2025-03-06 d4.Medical device lot#: 5065193 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-01-27 h4.Device manufacture date: 2025-01-30 d4.Medical device lot#: 5030326 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-08-12 h4.Device manufacture date: 2025-08-28 d4.Medical device lot#: 5225850 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-03-10 h4.Device manufacture date: 2025-03-06 d4.Medical device lot#: 5065231 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-04-14 h4.Device manufacture date: 2025-04-16 d4.Medical device lot#: 5106335 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-05-19 h4.Device manufacture date: 2025-05-21 d4.Medical device lot#: 5141823 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-06-02 h4.Device manufacture date: 2025-06-05 d4.Medical device lot#: 5156638 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-06-10 h4.Device manufacture date: 2025-06-12 d4.Medical device lot#: 5163066 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-08-05 h4.Device manufacture date: 2025-08-06 d4.Medical device lot#: 5218627 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-08-19 h4.Device manufacture date: 2025-09-03 d4.Medical device lot#: 5232958 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-04-07 h4.Device manufacture date: 2025-04-09 d4.Medical device lot#: 5099183 d4.Unique identifier (udi) #: (b)(4).D4.Medical device expiration date: 2026-06-24 h4.Device manufacture date: 2025-06-25 d4.Medical device lot#: 5176856 d4.Unique identifier (udi) #: (b)(4).Investigation summary - material 221788 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for all batches reported was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr was reviewed to confirm the following: --the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.--all autoclave parameters conformed to the validated cycle parameters for this product.--the minimum f0 for this product was met.The complaint history was reviewed, and no other complaints have been taken on batch 5065193.Retention samples from batch 5065193 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.Retention samples from batch 5030326 were not available for inspection.The complaint history was reviewed, and no other complaints have been taken on batch 5030326 for contamination.The complaint history was reviewed, and no other complaints have been taken on batch 5225850.Retention samples from batch 5225850 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5065231.Retention samples from batch 5065231 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5141823.Retention samples from batch 5141823 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5156638.Retention samples from batch 5156638 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5163066.Retention samples from batch 5163066 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5218627.Retention samples from batch 5218627 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5232958.Retention samples from batch 5232958 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5099183.Retention samples from batch 5099183 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.The complaint history was reviewed, and no other complaints have been taken on batch 5176856.Retention samples from batch 5176856 (10 tubes) were available for inspection.All 10 tubes were inspected; no defects were observed.For further investigation two tubes were placed into incubation for seven days to test for contamination.One retention tube was placed into the 20 to 25 degrees celsius incubator, and one retention tube was placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.Retention samples from batch 5106335 were not available for inspection.The complaint history was reviewed, and no other complaints have been taken on this batch for contamination.No photos or returns were provided for this investigation.As no returns or photos were provided and retention sample inspection did not show evidence of defect, this complaint is not confirmed.No complaint trends have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for defects.
|
