MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-18 for CATH PACK 89-7059 manufactured by Deroyal Industries, Inc..
[124671205]
Investigation summary: an internal complaint (b)(4) was received indicating that a convenience kit (finished good 80-7049, lot 47987324) contained a syringe that was leaking. The end user reported that the syringe plunger was loose and allowing air to enter the line when pushing fluids. A sample was returned to deroyal for evaluation. The complaint investigator performed a test on the returned sample to see if air bubbles leaked into the syringe. The test confirmed the customer's complaint. Air bubbles were seen forming around the seal of the plunger. The finished good work order was reviewed for possible discrepancies that may have contributed to the reported issue. No discrepancies were identified. The bill of material for the finished kit was reviewed to identify the affected component, which was determined to be raw material (b)(4), a 20cc luer lock syringe. This raw material syringe is supplied to deroyal by (b)(4). A supplier corrective action request (scar) was issued to (b)(4). The returned sample also was forwarded to (b)(4) for evaluation on october 3, 2018. As of the date of this report, a response has not been received. The 2016-2018 scar and supplier notification letter logs were reviewed for similar complaints. Similar complaints were identified. Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs. 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
[124671206]
The 20ml luer lock syringe contained in the convenience kit is leaking and the plunger is loose. Air is getting into the line when pushing fluids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00005 |
| MDR Report Key | 7978634 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-18 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-10-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CATH PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2018-10-18 |
| Returned To Mfg | 2018-10-03 |
| Model Number | 89-7059 |
| Lot Number | 47987324 |
| 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 | 2018-10-18 |