MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-01 for CARDIAC CATHETER TRAY 50-13119 manufactured by Deroyal Industries, Inc..
[110042813]
Investigation summary: an internal complaint ((b)(4)) was received for a cardiac catheterization tray (finished good 50-13119, lot 46982046), which indicated there was lint and loose threads on a towel contained within the tray. A sample was returned to deroyal for review. The returned sample did contain loose threads. The investigator reviewed the work order for possible discrepancies that may have contributed to the reported issue. No discrepancies were identified. The bill of materials for the finished good was reviewed, and the affected (b)(4) material was identified as part number 5-5338, a green operating room towel. Lot mapping shows that this towel is supplied to deroyal by (b)(4). A supplier notification letter was sent to (b)(4) to notify them of the reported event. The returned sample also was forwarded to (b)(4) and was received may 16, 2018. 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
[110042814]
Towels contained in a cardiac cath tray are linting. Random loose strands of thread are falling off of the towels. The end user is concerned the lint or thread could end up in a heart catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00002 |
| MDR Report Key | 7561356 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-06-01 |
| 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 | 3 |
| Brand Name | CARDIAC CATHETER TRAY |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2018-06-01 |
| Returned To Mfg | 2018-05-11 |
| Model Number | 50-13119 |
| Lot Number | 46982046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-01 |