MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for BD PAXGENE? BLOOD DNA TUBE 761165 manufactured by Becton, Dickinson And Company (bd).
[145426211]
Device evaluated by mfr: 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
[145426212]
It was reported that ten bd paxgene? Blood dna tube did not fill up to 2 ml, resulted in lower gdna yield. The following information was provided by the initial reporter: "this shows the volume of fluid in the tubes all using standard procedure for sample collection. This is nowhere near 2 ml that it should be. Our previous tubes were performing just fine, but our processing lab called to alert us to low volumes being collected. When we checked w/ phlebotomy, they had not changed any procedures for collection. This testing confirms in my mind that it is a defect in the tubes. I support the paxgene blood rna & dna tubes as well as a handful of other vacutainer tubes that fall under cell & biomarker preservation including cpt tubes. Per your email you reference catalog number 761165. Can you verify if it is 761165 which is the paxgene blood dna tube or 762165 which is the paxgene blood rna tube? If so, paxgene blood dna tubes should contain sufficient vacuum to draw 2. 0 ml of blood maintaining the optimum blood to additive ratio. Towards the end, the blood collection slows somewhat and the tube should be held below the level of the patient? S arm but the tube should not be removed from the holder until the blood completely stops flowing. I also want to verify that they are using a safety lock or push button blood collection set with 12 inch tubing and adaptor as directed in the product insert. One additional required step is to include the paxgene tubes last (dna before rna) in the draw series as another tube or alternatively a? Primer? Tube should be collected first to clear the 200ul of air or void volume from the wing set tubing. I will need to file an internal product incident report so will need customer contact information including name, phone number, institution and date of occurrence so that our complaints team can follow up. In addition, if they could indicate the total number of failed tubes and approximate actual amount of blood drawn that would be helpful as well. Replacement of the defective tubes will not be a problem, please indicate the address where they need to be sent. Regarding combining tubes: since this is a regulated medical device i cannot endorse deviation from the approved protocol but would be happy to speak with your customer about options for the short drawn samples. Yield and quality will depend on the actual volume of blood they were able to harvest. For example 1. 5 ml would yield more than 0. 5 ml due not only to total gdna available but also the deviation from the ideal additive:blood ratio.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00381 |
| MDR Report Key | 8475603 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2018-06-13 |
| Date Added to Maude | 2019-04-02 |
| 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 |
| 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 AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD PAXGENE? BLOOD DNA TUBE |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2019-04-02 |
| Catalog Number | 761165 |
| Lot Number | 8164968 |
| Device Expiration Date | 2019-06-30 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-02 |