MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-06-12 for ANGEL WING 23G BCS W/LUER ADPTR 8881225307 8881225037 manufactured by Tyco Healthcare/kendall.
[447962]
A customer had a problem with an angel wing. The customer stated that after drawing blood on a patient, the butterfly malfunctioned. The needle slipped out of safety piece and remained in the patients arm.
Patient Sequence No: 1, Text Type: D, B5
[7837068]
The process begins by cleaning the fixutre, 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 siliconized. 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 re moved to a station where the tube assembly is added to the angle 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 ina 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 eliminate 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 | 1282497-2006-00018 |
| MDR Report Key | 709843 |
| Report Source | 00 |
| Date Received | 2006-06-12 |
| Date of Report | 2006-04-25 |
| Date of Event | 2006-01-24 |
| Date Reported to Mfgr | 2006-04-25 |
| Date Mfgr Received | 2006-04-25 |
| Date Added to Maude | 2006-05-11 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | FABRICA BLVD INSURGENTES |
| Manufacturer City | LA MESA, TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL WING 23G BCS W/LUER ADPTR |
| Generic Name | ANGEL WING BLOOD COLLECTION DEVICE |
| Product Code | GJE |
| Date Received | 2006-06-12 |
| Model Number | 8881225307 |
| Catalog Number | 8881225037 |
| Lot Number | 5315528 |
| ID Number | * |
| Device Expiration Date | 2010-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 698892 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Baseline Brand Name | MONOJECT |
| Baseline Generic Name | BLOOD COLLECTION SET |
| Baseline Model No | 8881225307 |
| Baseline Device Family | SAFETY BLOOD COLLECTION SETS AND ACCESSORIES |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K940961 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-12 |