MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-24 for BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT 221788 manufactured by Bd Diagnostics.
[865120]
Customer called to report that an employee was opening a tube and the tube shattered in the person's hand. The employee was cut and required three stitches. The customer was unable to provide a lot number and said that he did not have any more of the tubes left. The customer remarked that this was a single isolated incident, and he did not think that the tube was tightly capped since the rest of the lot did not have tight caps. The customer said that the employee is ok and has returned to work.
Patient Sequence No: 1, Text Type: D, B5
[8074303]
Return material from the customer was unavailable for investigation. The customer could not provide a lot number; therefore, retention material could not be examined. A review of the complaint system was conducted and show non other report of this defect on this product catalog number. Although the customer indicated that the caps were not too tight, investigation by product family noted that the cap used on this tube type was identified as a contributing factor leading to occurrences where some caps required higher than usual removal force. For this catalog number, tubes made after 2008 have utilized a new cap shell. These tubes show improvement in the amount of force required to remove the cap from the tube. Bd will continue to monitor this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2008-00008 |
| MDR Report Key | 1064500 |
| Report Source | 05 |
| Date Received | 2008-06-24 |
| Date of Report | 2008-06-23 |
| Date of Event | 2008-06-02 |
| Date Mfgr Received | 2008-06-02 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-06-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES TILLMAN |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164054 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 250 SCHILLING CIRCLE |
| Manufacturer City | COCKEYSVILLE MD 21030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21030 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT |
| Product Code | JSG |
| Date Received | 2008-06-24 |
| Catalog Number | 221788 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1033007 |
| Manufacturer | BD DIAGNOSTICS |
| Manufacturer Address | 250 SCHILLING CIRCLE COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-24 |