MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for PICC TRAY 89-6417 manufactured by Deroyal Industries, Inc..
[54153570]
Root cause: the placement of the instruments within the tray allowed them to shift during shipping. Corrective action: the tray engineering department built a sample of this tray and rearranged the instruments, placing them in separate packaging from the other components in the tray. This placement will provide an extra barrier between the instruments and the outer packaging of the tray. An engineering change order ((b)(4)) was initiated and implemented to make this change effective. Investigation summary an internal complaint ((b)(4)) was received indicating that while unpacking a picc tray (finished good (b)(4), lot number 42286537), a pair of scissors came through the pack and cut an end user's hand. The device master record was reviewed and no discrepancies were identified that would contribute to this issue. No discrepancies were found. A sample was unavailable for evaluation. Therefore, the exact placement of the scissors within the pack could not be determined. No inventory was available for review at the distribution center. Preventive action: due to this being an isolated incident, a preventive action is not required. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[54153571]
He was unpacking a case of picc packs (finished good (b)(4), lot number 42286537) and a pair of scissors came through the pack and cut his hand. Since the scissors came through the pack wrapping, he will need one replacement pack. Once the pack was compromised, he opened the pack to see how the scissors were protected and found them upright.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2016-00024 |
| MDR Report Key | 5906866 |
| Date Received | 2016-08-26 |
| Date of Report | 2016-07-26 |
| Date of Event | 2016-07-29 |
| Date Mfgr Received | 2016-07-29 |
| Date Added to Maude | 2016-08-26 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PICC TRAY |
| Generic Name | CENTRAL VENOUS CATHETER DRESSING CHANGE KIT |
| Product Code | PEZ |
| Date Received | 2016-08-26 |
| Catalog Number | 89-6417 |
| Lot Number | 42286537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-26 |