MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-28 for NEURO SPONGE 30-054 manufactured by Medsorb Dominicana.
[74156914]
Investigation summary: an internal complaint (b)(4) was received indicating a neuro sponge (part number 30-054, lot 16f2497) failed during use. Pieces of the sponge were breaking off, causing a delay in surgery as health professionals manually removed the pieces that separated from the device. No injury to the patient occurred as a result of this failure. The actual device was not available for return. However, a sample from the same lot number was returned. Deroyal received this sample april 10, 2017, and forwarded it to the supplier for evaluation. The neuro sponge is supplied to deroyal by (b)(4). A supplier corrective action request was issued to (b)(4). A response is due may 15, 2017. As of the date of this report, a response has not been received. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[74156915]
The sponges are not pulling apart very well and are sticking together. There are pieces of the sponge (like strings) coming off during surgery. It delayed the procedure because they had to make sure none were left on the patient before they closed up. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[96132073]
Root cause: the raw material sponge is manufactured by (b)(4). Therefore, a supplier corrective action request was issued to (b)(4). In its response, (b)(4) stated the horn of the machine is showing signs of wear and needed replacement. This contributed to the reported failure of the sponges sticking together. Regarding the detachment of strings, (b)(4) indicated the string is available for location of the sponge but is not meant to be used to remove or relocate the sponge, which is stated within the instructions for use. The root cause for string detachment is usually associated with use error. Corrective action: (b)(4) has installed a new horn on the machine. Investigation summary: an internal complaint ((b)(4)) was received indicating a neuro sponge (part number 30-054, lot 16f2497) failed during use. Pieces of the sponge were breaking off, causing a delay in surgery as health professionals manually removed the pieces that separated from the device. No injury to the patient occurred as a result of this failure. The actual device was not available for return. However, a sample from the same lot number was returned. Deroyal received this sample april 10, 2017, and forwarded it to the supplier for evaluation. The work order was reviewed for possible discrepancies that may have contributed to the reported event. No discrepancies were identified. The neuro sponge is supplied to deroyal by (b)(4). A supplier corrective action request was issued to (b)(4). A response was received initially april 13, 2017 and revised june 5, 2017. The response was reviewed and accepted by deroyal personnel june 6, 2017. The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints. Similar complaints for the item were identified. Deroyal will continue to monitor post-market feedback. Preventive action: in its scar response, (b)(4) stated heightened awareness of the defect occurrence has been documented and personnel working with the product have been informed. The investigation is complete. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[96132074]
The sponges are not pulling apart very well and are sticking together. There are pieces of the sponge (like strings) coming off during surgery. It delayed the procedure because they had to make sure none were left on the patient before they closed up. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2017-00013 |
| MDR Report Key | 6531151 |
| Report Source | USER FACILITY |
| Date Received | 2017-04-28 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2017-04-28 |
| 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 | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURO SPONGE |
| Generic Name | GAUZE/SPONGE, INTERNAL |
| Product Code | EFQ |
| Date Received | 2017-04-28 |
| Returned To Mfg | 2017-04-10 |
| Model Number | 30-054 |
| Lot Number | 16F2497 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDSORB DOMINICANA |
| Manufacturer Address | ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS SAN PEDRO DE MACORIS DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-28 |