MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for BD BBL? BIO-BAG? ENVIRONMENTAL CHAMBER TYPE CFJ 261212 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[113741461]
Investigation: investigation summary: after reviewing the dhr no internal rejects related to broken/damaged was found during manufacturing process. A complaint history check was performed, and this is the 1st complaint reported for the injury (broken / damaged) on lot number 7156506 and is the 1st complaint received with this type of defect on the last 12 months related to catalog 261212. Investigation conclusion: due to no samples to evaluate were received it was not possible to determinate if the product manufacture could contribute to the reported failure. However based on the product design is very unlikely to have this kind of situations since the ampoule in the generator needs to perforate the following components (tube, sleeve, label & anaerobic bag) before injury to the customers. Root cause description: based on the nature of the reported defect without sample and/or any picture of the failed product the probable root cause could not be determinate.
Patient Sequence No: 1, Text Type: N, H10
[113741462]
It was reported that while using a bd bbl? Bio-bag? Environmental chamber type cfj a lab assistant was cut through their glove attempting to crush the glass ampoule. The lab assistant received medical intervention at an emergency room following the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2018-00222 |
| MDR Report Key | 7679811 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-06-25 |
| Device Manufacturer Date | 2017-06-15 |
| Date Added to Maude | 2018-07-11 |
| 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 | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLOSIO NO. 579 |
| Manufacturer City | NOGALES |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD BBL? BIO-BAG? ENVIRONMENTAL CHAMBER TYPE CFJ |
| Generic Name | GAS-GENERATING DEVICE |
| Product Code | KZJ |
| Date Received | 2018-07-11 |
| Catalog Number | 261212 |
| Lot Number | 7156506 |
| Device Expiration Date | 2018-10-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Address | PERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-11 |