MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-12 for ARG DLEE MUC TP W/FLT 20CC 10 FR STRL 8888257469 manufactured by Covidien.
[50100879]
An investigation is currently under way, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[50100880]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an open suction catheter. The customer states that the product is labeled as a 10fr catheter; however, when opened and compared to other delees it appears smaller than a 10fr.
Patient Sequence No: 1, Text Type: D, B5
[53926040]
Submit date: 08/25/2016. One sample received had lot# 152680292x. A device history record (dhr) of the sample lot# was performed and confirmed that the product was produced accomplishing all quality requirements and was released according to all established procedures. One sample was received for evaluation. The received sample was evaluated visually and functionally and verified the condition reported. An 8 fr catheter was assembled instead of a 10 fr catheter. After investigation, the possible root cause was concluded as a supplier (possibly supplied incorrect catheter) or manufacturing issue (possible product mix during process). The supplier bought catheter was removed from ship to stock status from the manufacturing incoming inspection department. First article inspection was placed on the manufacturing floor and a qa alert was posted in the incoming inspection department as well as the manufacturing floor. The dhr investigation of lots before and after has shown no similar conditions at this time. A corrective and preventative action (capa) was opened at the manufacturing site to address this event. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2016-00478 |
| MDR Report Key | 5787087 |
| Date Received | 2016-07-12 |
| Date of Report | 2016-06-13 |
| Date Mfgr Received | 2016-08-25 |
| Date Added to Maude | 2016-07-12 |
| 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, LA MESA |
| Manufacturer City | TIJAUNA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARG DLEE MUC TP W/FLT 20CC 10 FR STRL |
| Generic Name | OPEN SUCTION CATHETER |
| Product Code | BYZ |
| Date Received | 2016-07-12 |
| Model Number | 8888257469 |
| Catalog Number | 8888257469 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-07-12 |