MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-07 for BD MICROTAINER? CONTACT-ACTIVATED LANCET 366592 manufactured by Becton Dickinson.
[33013973]
In this emdr, bd corporate headquarters in (b)(4) has been listed in sections as high tech laboratory is an oem manufacturing site. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: the device was manufactured between 01/22/2015 - 01/27/2015.
Patient Sequence No: 1, Text Type: N, H10
[33013974]
It was reported that while using a bd microtainer? Contact-activated lancet a nurse obtained a contaminated needle stick injury because the needle did not retract. There were no reported medical interventions for this incident.
Patient Sequence No: 1, Text Type: D, B5
[35116269]
One used sample and five photos of the device were returned for evaluation. A visual inspection of the unit revealed that the needle had retracted. The returned device was disassembled and no defects were observed that would cause the failure of the needle to retract after activation and puncture and no deviations were found with regard to needle protrusion length from the molding, cooperation of the needle with the housing, quality of springs, or correctness of assembly. A reserve sample from the same lot number was tested and all devices made a correct puncture and the needle retracted afterwards. A review of the device history record revealed no irregularities during the manufacture of the reported lot number v7n58a5. Conclusion: an absolute root cause for this incident cannot be determined. However, due to an increasing trend of the number of complaints for needle retraction failure and more frequent accidental needle stick injuries, bd had a teleconference with the oem manufacturer and it was determined that a capa would be opened for this issue. The bd capa number is (b)(4). Additionally, based on the analysis of samples provided by customers of previous complaints, it was determined that the main cause of failure of the needle to retract is too long needle protrusion length from the molding of the complete needle and planned actions are being taken under the capa (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243072-2015-00163 |
| MDR Report Key | 5271698 |
| Date Received | 2015-12-07 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-11-26 |
| Date Mfgr Received | 2015-11-26 |
| Date Added to Maude | 2015-12-07 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD MICROTAINER? CONTACT-ACTIVATED LANCET |
| Generic Name | LANCET |
| Product Code | FKM |
| Date Received | 2015-12-07 |
| Catalog Number | 366592 |
| Lot Number | V7M58A5 |
| Operator | NURSE |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-07 |