Zyno medical received an inverted pinch clamp issue from a distributor representative on 04/16/2019.A user facility representative called this distributor and stated that "for the past two weeks, there had been several instances of admin sets that had an inverted pinch clamp.There was no patient involved in any of these issues and no patient came to harm.Issue noticed (b)(6) 2019 by an rn.No medication was infused".The user facility representative also indicated that a few devices with inverted clamps would be sent back to the distributor for evaluation.The contract manufacturer of the affected device is becton, dickinson and company.
|
The reported complaint could not be confirmed.The distributor ((b)(4)) provided the following information to zyno medical on (b)(4) 2019: "none of the sets were returned and customer was unresponsive to follow-up phone calls on 4-23-2019, 4-24-2019, 5-3-2019 and 5-20-2019.On each call, (b)(4) was told by the receptionist that (b)(4) would get back to them and she did not.Customer was also unresponsive to follow-up emails sent on 4-16-2019, 4-19-2019, 4-24-2019 and 5-6-2019 asking if she was going to return the set.(b)(4) has therefore closed this customer feedback." since no device was returned, no testing could be performed.On 06/06/2019, zyno medical initiated a voluntary recall on this reported issue, and the affected device is within the scope of this recall.See recall report 3006575795-06/06/2019-001-r for additional information.
|