MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-04-04 for AW BCS 21GX7X3/4 W/LUER 8881225799 manufactured by Tyco/kendall Healthcare.
[441964]
A customer had a problem with the angel wing blood collection. The customer states that while withdrawing the angel wing from venipuncture site the needle separated from the hub.
Patient Sequence No: 1, Text Type: D, B5
[18724502]
One used sample was received an evaluated; the needle was already detached rom the hub; it was noticed that there is no evidence of presence of adhesive in the hub and on the needle, so it can be assumed that detachment of the needle was due to no adhesive applied on the hub-needle area. The process begins by cleaning the fixture, and then the fixture is placed over a transport belt. The fixture is then taken and laid over a firm support, and then 6 wings are placed in the fixture. Afterward the needles are inserted manually with the tip pointing to the operator, the clips are then placed on the wings and again the fixture is placed on the transporting belt. It arrives to the station where the adhesive is added to the needle via an injector system, subsequently the fixture is put in a transporting belt so it can go thru the uv chamber so the needle adhesive cures. When the fixture comes out of the chamber it is placed on a firm support and the needles are siliconzed. The fixture is then moved to a station where a tube segment is placed over the wing protecting the needle. The wings are taken from the fixture and are moved to a station where the tub assembly is added to the angel wing. The empty fixtures are sent to the beginning of the process where they are cleaned. The wings with the tube assembly are rolled and placed in a container, when the container is full it is moved to the multivac where the rolled angel wings are packed. An analysis showed that the potential root cause could have been a lack of bonding and a not a proper amount of adhesive fluid in the hub. An investigation team has been configured to elminate the potential root causes detected. A corrective and preventative action (capa) has also been initiated to address this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2006-00017 |
| MDR Report Key | 695625 |
| Report Source | 07 |
| Date Received | 2006-04-04 |
| Date of Report | 2006-04-03 |
| Date of Event | 2006-03-14 |
| Date Reported to Mfgr | 2006-04-03 |
| Date Mfgr Received | 2006-04-03 |
| Date Added to Maude | 2006-04-06 |
| 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 | ADRIENNE MARCELLUS, RN |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | TYCO/KENDALL HEALTHCARE |
| Manufacturer Street | 2498 ROLL DRIVE #727 |
| Manufacturer City | SAN DIEGO CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AW BCS 21GX7X3/4 W/LUER |
| Generic Name | BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2006-04-04 |
| Model Number | 8881225799 |
| Catalog Number | 8881225799 |
| Lot Number | 5329165 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 684743 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 2498 ROLL DRIVE #727 SAN DIEGO CA 92154 US |
| Baseline Brand Name | AW BCS 21GX7X3/4 W/LUER |
| Baseline Generic Name | BLOOD COLLECTION |
| Baseline Model No | 8881225799 |
| Baseline Catalog No | 8881225799 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-04 |