MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for MEDLINE ARTERIOGRAM PACK DYNJ42696B manufactured by Medline Industries, Inc., Laredo.
[144135710]
Wood chip found in sterile arteriogram pack. Discovered upon opening and pack. Entire pack isolated and removed from the ir room. New pack opened but from the same lot. All inventory is from the same lot. Second pack opened and wood chip found in that one as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086361 |
| MDR Report Key | 8577877 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-19 |
| Date of Event | 2019-04-18 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDLINE ARTERIOGRAM PACK |
| Generic Name | CARDIAC, CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2019-05-02 |
| Model Number | DYNJ42696B |
| Catalog Number | DYNJ42696B |
| Lot Number | 19BDD121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC., LAREDO |
| Brand Name | MEDLINE ARTERIOGRAM PACK |
| Generic Name | CARDIAC, CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2019-05-02 |
| Model Number | DYNJ42696B |
| Catalog Number | DYNJ42696B |
| Lot Number | 19BDD121 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC., LAREDO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |