MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for BD? DEHP FREE INFUSION SET 590502 manufactured by Becton Dickinson.
[83312041]
Results: a sample was returned for evaluation. A hair was found inside the iv tube. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Conclusion: based on the investigation result of the complaint case the hair inside the iv set tube was a human hair. We suppose that when the two parts(sleeve stopper and y-connector) were assembled together, a hair may have stuck onto one of them and flowed inside the y-connector due to static electricity. Defect due to insufficient cleanness of work stand or work floor or smock. Capa (b)(4) has been opened. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83312042]
It was reported that a hair was found in the tubing of a bd? Dehp free infusion set during use. No injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2017-00090 |
| MDR Report Key | 6810329 |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2017-04-27 |
| Date Added to Maude | 2017-08-22 |
| 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 | 0 |
| Brand Name | BD? DEHP FREE INFUSION SET |
| Generic Name | IV TUBING |
| Product Code | FPK |
| Date Received | 2017-08-22 |
| Returned To Mfg | 2017-07-27 |
| Catalog Number | 590502 |
| Lot Number | 2704101 |
| Operator | NURSE |
| Device Availability | R |
| 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 | 2017-08-22 |