MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for AW TRANSFER SET FOR BACT ALERT 8881225241 manufactured by Covidien.
[45516978]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[45516979]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a syringe. The customer states a technician was removing an angel wing from its packaging when he noticed the needle was detached from the protective casing. The point supervisor was notified. No patient was involved and no impact to the procedure or clinician. The product was being used for sterility testing on blood sample.
Patient Sequence No: 1, Text Type: D, B5
[54044007]
The customer states a technician was removing an angel wing from its packaging when he noticed the needle was detached from the protective casing. The point supervisor was notified. No patient was involved and no impact to the procedure or clinician. The product was being used for sterility testing on blood sample. The report refers to product code 8881225241- female blood culture transfer with lot number 152190284x. The dhr of the lot number reported was reviewed, and was confirmed that the products were produced accomplishing quality requirements and was released according to established procedures. There was received one sample for evaluation, sample showed that the needle was detached from the holder; it seems that material was not properly assembled during manufacturing process. Root cause could be related to misalignment during the pneumatic press process. A quality circle was opened to follow up this issue, actions were the following: maintenance order to level de press. Personnel were retrained on procedure related to needle press. A poka-yoke was implemented on work station.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2016-00198 |
| MDR Report Key | 5648063 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-04-10 |
| Date Mfgr Received | 2016-08-24 |
| Date Added to Maude | 2016-05-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD INSURGENTES LIBRIAMENTO A LA P |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AW TRANSFER SET FOR BACT ALERT |
| Generic Name | TRANSFER SET |
| Product Code | FMI |
| Date Received | 2016-05-11 |
| Model Number | 8881225241 |
| Catalog Number | 8881225241 |
| Lot Number | 52190284X |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA TIJUANA MX |
| Brand Name | AW TRANSFER SET FOR BACT ALERT |
| Generic Name | TRANSFER SET |
| Product Code | KSB |
| Date Received | 2016-05-11 |
| Model Number | 8881225241 |
| Catalog Number | 8881225241 |
| Lot Number | 52190284X |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-11 |