MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-26 for 13 X 75 MM X 4.0 ML BD VACUTAINER? PLUS LAVENDER BD HEMOGARD? CLOSURE 367861 manufactured by Becton, Dickinson & Co..
[81255917]
Date of event: unknown. The date received by manufacturer has been used for this field. Results: two used samples were returned. The device history review showed no issues were found. There were no related quality notifications. Bd pas received one sample from the customer facility for investigation. The customers sample was evaluated and the customer? S indicated failure mode of? Stopper popoff? With the incident lot was not observed as the sample met the required specifications. Water fill testing was conducted on the customer sample and? Stopper popoff? Was not observed. Additionally, 20 retention samples were selected from in-house inventory and inspected for? Stopper popoff? And no issues were observed as all retention samples met specifications. The manufacturing records were reviewed and no issues were identified. Conclusion: an absolute root cause for this incident cannot be determined (b)(4) was unable to confirm the customer? S indicated failure mode because the defect was not observed in the sample and the water fill test on the retention samples. Udi# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81255918]
It was reported the stoppers were popping off with the 13 x 75 mm x 4. 0 ml bd vacutainer? Plus lavender bd hemogard? Closure. No medical interventions reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00072 |
| MDR Report Key | 6745511 |
| Date Received | 2017-07-26 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-04-21 |
| Device Manufacturer Date | 2016-09-09 |
| Date Added to Maude | 2017-07-26 |
| 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 | 8015652845 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| 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 | 0 |
| Brand Name | 13 X 75 MM X 4.0 ML BD VACUTAINER? PLUS LAVENDER BD HEMOGARD? CLOSURE |
| Generic Name | COLLECTION TUBE |
| Product Code | FKA |
| Date Received | 2017-07-26 |
| Returned To Mfg | 2017-05-03 |
| Catalog Number | 367861 |
| Lot Number | 6253705 |
| Device Expiration Date | 2018-01-31 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-26 |