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 BLOOD COLLECTION TUBE UNKNOWN manufactured by Becton Dickinson.
[186284286]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Device manufacture date: unknown. There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog or a 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. 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
[186284287]
It was reported that erroneous results occurred after use with a unspecified bd blood collection tube. The following information was provided by the initial reporter, "he stated that the initial sample was hemolyzed. I explained that this could be the cause of the high k+ result. He asked about centrifugation speeds. I sent him the link to the ifu, the sst tech talk and troubleshooting erroneous potassium's in a clinical laboratory setting wall chart. He will send me the catalog/lot# of the sst tube. (2 of 2) it was reported that the potassium results were high. Result of 4. 8 in house. 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. Event date is unknown (last week). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00445 |
| MDR Report Key | 9856441 |
| 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 BLOOD COLLECTION TUBE |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-19 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 |