MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-19 for UNSPECIFIED BD VACUTAINER? SST BLOOD COLLECTION TUBES UNKNOWN manufactured by Becton Dickinson.
[186283574]
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. 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: 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
[186283575]
It was reported that the potassium results were high with an unspecified bd vacutainer? Sst blood collection tubes. The following information was provided by the initial reporter: (1 of 2 complaints) first test resulted in 6. 1 and the second draw resulted in 4. 8. Customer stated that the first draw, 6. 1, was done at an outpatient facility and the second was done in house. Stated that different sites use different centrifuges and wants to know if this could be the issue. No aes and confirmed address with customer. Customer will provide catalog# upon request. Hearing from other outpatient locations that the potassium results appear to be elevated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00453 |
| MDR Report Key | 9857740 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| 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 |
| 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 | UNSPECIFIED BD VACUTAINER? SST BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-19 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 2020-03-19 |