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 2018-01-16 for BD BBL? VENTING UNIT 271056 manufactured by Becton, Dickinson & Co..
[97387740]
Investigation: no product returns, photos, or customer reports were received. Tech services has confirmed: the customer was wearing ppe (including gloves) when the incident occurred, results of the customer? S baseline testing is unknown, and the customer? S incident aligns with what is defined as an s2 severity level for this product (material 271056). The complaint investigation included a review of qn trends for the batch. No qns were noted on the batch. Complaint trending was performed and no trends were identified for this event type (needle stick). An inspection of retention samples from the complaint batch (170401) determined that the incident did not occur due to product defect. The retention sample also indicated that this product was labeled with revision 02 of the label which does not contain warnings for the user. All batches produced going forward will be labeled with revision 03 of the label that includes the warnings for the user. A cid meeting was held (reference cid #(b)(4)) to determine if a capa was required. Based on a review of complaint trends and the severity for this incident, no further corrective action is required. Investigation conclusion: no product returns, photos, or customer reports were received. This complaint is confirmed based on a review of the current labeling and customer report. Bd id/ast plant quality will continue to closely monitor for trends associated with this material and incident. Root cause description: specific root cause could not be determined for this incident. However, there was no defect identified with the product that would have caused this event. Based on the evaluation of severity and occurrence of this event no further corrective action is required. Labeling on batches going forward will contain user warnings.
Patient Sequence No: 1, Text Type: N, H10
[97387741]
It was reported that a the customer stuck themselves when removing the vent on a bd bbl? Venting unit. The vent has been used to dispense blood onto plates.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2017-00012 |
| MDR Report Key | 7195416 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-01-16 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-09 |
| Date Mfgr Received | 2017-12-22 |
| Date Added to Maude | 2018-01-16 |
| 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 | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BBL? VENTING UNIT |
| Generic Name | BLOOD CULTURE |
| Product Code | JTA |
| Date Received | 2018-01-16 |
| Catalog Number | 271056 |
| Lot Number | 170401 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-16 |