MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-05-06 for CARDINAL HEALTH S/P ORANGE 50G GLUCOSE TOLERANCE B5395-7A manufactured by Nerl Diagnostics Llc..
[832776]
In 2008, patient was administered dosage of cardinal health s/p orange 50g glucose tolerance beverage. Patient drank beverage directly out of glass bottle; patient's tongue came into contact with a piece of glass and noticed blood. Patient spit piece of glass back into bottle. Manufacturer was made aware of this event on 4/8/2008.
Patient Sequence No: 1, Text Type: D, B5
[7994406]
In response to the receipt of this customer complaint, we retrieved the bottle from the facility involved with the patient and conducted a risk assessement. We decided to recall the entire lot of product which was shipped to one distributor. We are working with that distributor in order to ensure that all end users are notified of the recall. In addition, to ensure that the product remains free of particulate material (broken glass), our regulatory affairs and operations staff visited the site to conduct an assessment of fill-line to determine if any additional preventative actions could be implemented. Specifically, wer reviewed this event with the entire production staff as an awareness follow up and conducted a complete review, filler cleaning procedure for broken bottles, and reviewed line guarding procedures for glass bottles. We updated the sop to include checking the bottle seat area for any broken glass during an event and decided to increase the number of bottles discarded in the event of a broken bottle during the fill. We also will add additional emergency e-stop switches to allow the operator to shut-down the line in a more timely manner by 05/21/2008. Finally we have quarantined other unrelated lots of product in order to conduct random testing to ensure that no particulate matter exists in those lots. We believe that this occurrence is an isolated event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1125464-2008-00001 |
| MDR Report Key | 1038471 |
| Report Source | 08 |
| Date Received | 2008-05-06 |
| Date of Report | 2008-04-08 |
| Date of Event | 2008-03-31 |
| Date Mfgr Received | 2006-04-08 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2009-10-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TINA LOMBARI |
| Manufacturer Street | 14 ALMEIDA AVENUE |
| Manufacturer City | EAST PROVIDENCE RI 02914 |
| Manufacturer Country | US |
| Manufacturer Postal | 02914 |
| Manufacturer Phone | 4018242046 |
| Manufacturer G1 | NERL DIAGNOSTICS |
| Manufacturer Street | 3800 DILLON ST. |
| Manufacturer City | BALTIMORE MD 21224 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21224 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL HEALTH S/P ORANGE 50G GLUCOSE TOLERANCE |
| Product Code | MRV |
| Date Received | 2008-05-06 |
| Returned To Mfg | 2008-04-18 |
| Catalog Number | B5395-7A |
| Lot Number | 4067 |
| ID Number | (01) 00380470003610 |
| Device Expiration Date | 2009-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NERL DIAGNOSTICS LLC. |
| Manufacturer Address | 3800 DILLON ST. BALTIMORE MD 21224 US 21224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-06 |