MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-03-27 for 216 NDL 22X1 A3 TW 8881216066 manufactured by Tyco/kendall Healthcare.
[477399]
It was reported to tyco/kendall healthcare that a customer had a problem with the 22x1 blood collection needle. The customer states that the needle broke during use on a pt.
Patient Sequence No: 1, Text Type: D, B5
[15307687]
According to the lot history records, total production for lot 529435 was with no defects detected in 625 samples inspected. There have been no other complaints against lot 529435. A search of our complaint database from june 2000 did not show any prior occurrences of this defect for this item number. An expanded search from june 2000 did not show any prior occurrences of broken needles for the entire blood collection needle product family. There were no samples submitted with the complaint therefore the defect could not be confirmed. All lots of hypodermic needle tubing are statistically sampled and tested for stiffness and breakage the 22 gage tubing must withstand 20 cycles of bending at an included angle of 50 degrees and a contact point of 7/8. This test subjects the tubing to much more severe condtions than would be expected to occur in actual needle use. A cause cannot be determined without more information or a sample to examine.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017768-2006-00013 |
| MDR Report Key | 692901 |
| Report Source | 06 |
| Date Received | 2006-03-27 |
| Date of Report | 2006-03-23 |
| Date of Event | 2006-01-01 |
| Date Reported to Mfgr | 2006-03-23 |
| Date Mfgr Received | 2006-03-23 |
| Date Added to Maude | 2006-03-30 |
| 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 | 2010 INTL SPEEDWAY BLVD |
| Manufacturer City | DELAND FL 32720 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32720 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 216 NDL 22X1 A3 TW |
| Generic Name | BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2006-03-27 |
| Model Number | 8881216066 |
| Catalog Number | 8881216066 |
| Lot Number | 529435 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 682050 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 2010 INTERNATIONAL SPEED DELAND FL 32720 US |
| Baseline Brand Name | 216 NDL 22X1 A3 TW |
| Baseline Generic Name | BLOOD COLLECTION |
| Baseline Model No | 8881216066 |
| Baseline Catalog No | 8881216066 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-27 |