MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for DYNJ905269B manufactured by Medline Industries Inc..
[138567963]
It was reported that the yellow passing tray (from custom the c-section pack) was received with a crack and missing pieces. Reportedly, a plastic piece went into the patient's abdomen. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. It is unknown how the broken piece from the yellow passing tray reached the surgical site and how the broken piece was removed from the surgical site. Due to the reported event, this medwatch is being filed. A sample was returned for evaluation and the complaint was confirmed. The placement of the yellow passing tray was reviewed in the picture production placement form of this custom c-section pack. A definitive root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[138567964]
It was reported that a plastic piece from the yellow passing tray went into the patient's abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2019-00008 |
| MDR Report Key | 8407953 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-03-11 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | PASSING TRAY FROM TRINITY C-SEC W/LINEN CDS |
| Product Code | OHM |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2019-02-18 |
| Catalog Number | DYNJ905269B |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-11 |