MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-28 for STERILE DRAPE SLEEVES E5-81 66-DA-SD, FC1004 manufactured by Fhc, Inc..
[4825154]
An expiration date discrepancy of sterile drape sleeves, model e5-81, lot 150117, was found during an internal audit. Vendor paper work shows an expiration date of february 2018. The internal inventory and sales system shows an expiration date of may 4, 2017. Products made from this lot show an expiration date of may 4, 2018. (b)(4) products were made (catalog #66-da-sd and fc1004). (b)(4) units were shipped to (b)(4) different customers (packaged 20 units to a box). A product hold was immediately placed on the remaining internal stock, which was relabeled with the correct february 1, 2018 expiration date. Therefore, the (b)(4) customers who had purchased the product were contacted via phone or personal visit on (b)(6) 2014 to issue a market withdrawal. The communication was followed-up with a formal market withdrawal letter. A process change was implemented and will be tested with the next vendor shipment of e5-81 drape sleeves.
Patient Sequence No: 1, Text Type: D, B5
[12433723]
(b)(4). Despite several attempts to contact the customer, fhc has had no reply communication regarding the status of the with product. All unopened returned boxes were relabeled with the correct expiration date. Opened boxes of product were destroyed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005677147-2014-00008 |
| MDR Report Key | 4080917 |
| Report Source | 07 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-07-28 |
| Date Mfgr Received | 2014-07-28 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHY MILLS |
| Manufacturer Street | 1201 MAIN ST |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal | 04287 |
| Manufacturer Phone | 2076665651 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE DRAPE SLEEVES |
| Generic Name | STERILE DRAPE SLEEVES |
| Product Code | MMP |
| Date Received | 2014-08-28 |
| Model Number | E5-81 |
| Catalog Number | 66-DA-SD, FC1004 |
| Lot Number | 150117 |
| Device Expiration Date | 2018-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FHC, INC. |
| Manufacturer Address | BOWDOIN ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-28 |