MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-18 for BD VACUTAINER? SERUM BLOOD COLLECTION TUBES 368660 manufactured by Becton, Dickinson & Co. (broken Bow).
[186301379]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: the customer did not provide bd pas with product catalog number or lot number information, when requested. After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint. If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
Patient Sequence No: 1, Text Type: N, H10
[186301380]
It was reported that erroneous results and incorrect additive were found after use with a bd vacutainer? Serum blood collection tube. The following information was provided by the initial reporter, (b)(6) 2020: received phone call. She does not want to file a complaint. She would like to know what additive is this clot activator as their reference lab rejected specimen due to clot activator in vacutainer. Tube was sent off to test microalbumin urine but was rejected. No other information is available, no samples available, no ack letter required and no closure letter needed. (b)(6) 2020: i explained to the customer that the nurses should not be using serum tubes to collect urine specimens. I sent her the link to the ifu to explain that the plastic serum tubes contain silicone and micronized silica particles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00292 |
| MDR Report Key | 9849874 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-18 |
| 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? SERUM BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-18 |
| Model Number | 368660 |
| Catalog Number | 368660 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-18 |