Results: bd received one sample from the customer in support of this complaint.
The failure mode was observed in the sample provided by the customer, and no additional abnormalities in the incoming material, assembly process or packaging process were observed in the batch record.
The indwelling needle was being used for 4 days (b)(6) it was fine for the first 3 and failed on the fourth.
Because the unit behaved normally for the first three days it was determined to be within specification.
(b)(4) cannot finalize the root cause of the plant as a result.
A review of the device history record revealed no irregularities during the manufacture of the reported lot number.
Conclusion: in conclusion, based on the current investigation, no abnormality was found at the beginning of using.
(b)(4) plant can't finalize the root cause for this kind of failure.
|
Medical device lot #: 7083015, medical device expiration date: 3/31/2020, device manufacture date: 3/24/2017.
Medical device lot #: 7110497, medical device expiration date: 4/30/2020, device manufacture date: 4/20/2017.
A device evaluation is anticipated, but has not yet begun.
Upon completion of the investigation, a supplemental report will be filed.
|