MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-11-05 for MICROSAFE PART# 030-083 manufactured by Safe-tec Clinical Products, Inc..
[21955438]
Safe-tec produces microsafe capillary tubes used in various blood test kits. On 10/05/2007, a customer, which is a distributor in another country, reported that one of their customer in a foreign country, which uses the capillary tubes in their test kits, received the wrong size tubes in a shipment. Mfr is supplied 40ul tubes in packages of 25 each with their unique label on each package. Mfr notified other mfr that they found several packages of 15ul tubes mixed in with 40ul tubes in their inventory. Mfr indicated that bags were mislabeled, one was returned from a laboratory in us (identity unk) and the rest of bags were found in a 100% inventory check. Only one lot of 40ul tubes was affected. Tubes are used in hiv test kits sold by mfr into the us. According to mfr, they notified the fda of the impact on their test kit and also initiated a product recall. They are treating the capillary tubes as components in their test kits. However, the devices can be considered to be finished devices of safe-tec, which is why this report has been prepared. Safe-tec has no info that any patients were involved.
Patient Sequence No: 1, Text Type: D, B5
[21995197]
Evaluation through visual inspection of units returned by mfr to safe-tec confirmed that units were 15ul tubes packaged with mfr-specific labels indicating 40ul tubes. Safe-tec conducted an internal investigation involving the subcontracted mfr. Process flow is as follows: sent to safe-tec for inspection, and then safe-tec sends the tubes to jorsow for repackaging into smaller quantities per customer requirements. New labels are applied per customer requirements. Upon review of processes and procedures in an internal investigation it was determined that the problem most likely was caused at the re-packager, jorsow, inc. Investigation determined that 15ul tubes in an open bulk bag were returned to inventory from the packaging line and mistakenly mixed with 40ul inventory. Jorsow has completed a 100% inspection of safe-tec inventory and confirmed that the problem was limited to one lot of 40ul tubes. All affected inventory was sold exclusively to mfr, has their unique label on each package, and all affected inventory was accounted for. Lots produced before and after the affected lot were inspected at trinity and were good. Corrective actions have been initiated at safe-tec and at jorsow to prevent a reoccurrence of the problem, including procedure changes for line clearance and return to inventory. Safe-tec is conducting a vendor inspection of jorsow to confirm their corrective actions. Mfr has accepted safe-tec's investigation and corrective action plan. All affected inventory has been accounted for, so no recall or field corrective action by safe-tec is necessary. Unless add'l data is obtained, this investigation is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2528905-2007-00001 |
| MDR Report Key | 939725 |
| Report Source | 01 |
| Date Received | 2007-11-05 |
| Date of Report | 2007-11-02 |
| Date of Event | 2007-10-05 |
| Date Mfgr Received | 2007-10-05 |
| Device Manufacturer Date | 2007-06-13 |
| Date Added to Maude | 2008-03-03 |
| 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 Street | 142 RAILROAD DR. |
| Manufacturer City | IVYLAND PA 18974 |
| Manufacturer Country | US |
| Manufacturer Postal | 18974 |
| Manufacturer Phone | 6103530200 |
| Manufacturer G1 | DRUMMON SCIENTIFIC, INC. |
| Manufacturer Street | 500 PKWY |
| Manufacturer City | BROOMALL PA 19008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19008 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSAFE |
| Generic Name | CAPILLARY BLOOD COLLECTION TUBE |
| Product Code | GIO |
| Date Received | 2007-11-05 |
| Returned To Mfg | 2007-10-16 |
| Catalog Number | PART# 030-083 |
| Lot Number | 1646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 958465 |
| Manufacturer | SAFE-TEC CLINICAL PRODUCTS, INC. |
| Manufacturer Address | IVYLAND PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-05 |