MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-19 for BD VACUTAINER? PST? GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBE 367962 manufactured by Becton, Dickinson & Co. (broken Bow).
[186299228]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd had not received samples or photos from the customer facility for evaluation. Additionally, bd was unable to determine the specific lot number associated with this complaint. Therefore, a review of the device history record could not be conducted.
Patient Sequence No: 1, Text Type: N, H10
[186299229]
It was reported that there was poor barrier separation with a bd vacutainer? Pst? Gel and lithium heparin (lh) 83 units blood collection tubes. The following information was provided by the initial reporter: customer called to report that the samples have been clogging the probe of the instrument, there is little floaties. They spin for 10 minutes. She stated this is an ongoing issue since they started using the tubes mid november. She did not know the lot numbers as they are covered by the labels. She provided the lot number they are using as a balance lot# 9344005. She is wanting to know if its possible to be overspinning? Additionally, on 2020-02-28 the bd sales consultant provided the following additional information: explained that the floaties could be fibrin and that will clog the probes. I reviewed mixing and centrifuge speed and time. She stated they are supposed to mix the tubes, and whether or not they are she does not know. They spin at 6000 rpm for 10 minutes. I explained that the correct speed is 1300 g and depends on the radius of the centrifuge. She stated that these floaties occur randomly, and cannot track them back to a certain phlebotomist or nurse, and that this has been going on since (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00295 |
| MDR Report Key | 9855502 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-19 |
| 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 & CO. (BROKEN BOW) |
| Manufacturer Street | 150 SOUTH 1ST AVENUE |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? PST? GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBE |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-19 |
| Model Number | 367962 |
| Catalog Number | 367962 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |