MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2020-01-02 for BD PHASEAL? INFUSION CLAMP M25 515085 manufactured by Becton Dickinson.
[178217467]
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. The lot # reported (191001) is not a manufactured lot for this device. The following information is believed to be correct, however, was not able to be confirmed: medical device lot #: 1910001. Medical device expiration date: 2024-09-30. Device manufacture date: 2019-11-07. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178217468]
It was reported that the infusion clamps were not functioning with a bd phaseal? Infusion clamp m25. The following information was provided by the initial reporter: it was reported that the infusion clamps would not click into place or close properly and that the tab would not lock into place. Additionally, the bd sales consultant provided the following additional information: i wanted to report an issue that took place today with several infusion clamps while at emory. Out of 3 boxes of 25, several of them would not "click" into place or close as they should, the small tab that locks the 2 sides together wouldn't lock. Out of 3 boxes, i would guess up to ~ 30% of the samples had this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-02935 |
| MDR Report Key | 9539635 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8015652341 |
| 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 PHASEAL? INFUSION CLAMP M25 |
| Generic Name | INTRAVASCULAR CATHETER SECUREMENT DEVICE |
| Product Code | KMK |
| Date Received | 2020-01-02 |
| Catalog Number | 515085 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-02 |