MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-27 for UMBILICAL CORD CLAMP 6833 manufactured by Deroyal Industries.
[5742622]
Clamp came off of baby's cord.
Patient Sequence No: 1, Text Type: D, B5
[13329005]
Investigation findings: initial investigation: no lot number or sample provided for investigation. Inventory was not checked as a visual inspection of the product would not reveal or detect the reported defect. Updated: a further review of the complaint has identified that the complaint will be required for updates. Deroyal regulatory department has been notified of the re-opening of the report. The sample was not returned and the lot number was not reported; therefore, it is unk as to if the product was of the previous design or the design that was implemented in 06/2012. The design change was implanted in 06/2012 and approved through (b)(4). Deroyal also evaluated the clamp compression force of the device through validation protocol (b)(4) - comparative testing of cord clamp compression force. Refer to the validation protocol (b)(4). The 2013, 2014, and 2015 qfi logs were reviewed utilizing the keyword "umbilical" to identify if customer complaints have been received for the raw material (b)(4) or finished goods that contain the raw material. There have been no complaints received during the review period. (b)(4). Correction: a correction has not been taken. Root cause analysis: initial investigation: undetermined, no lot number or sample was provided. Update: the true root cause for the reported issue is unable to be identified. Potential root causes have been identified but are not limited to the following: product defect; end user failing to follow the ifu and not ensuring the product was applied correctly and fully closed; and end user error failing to follow the ifu and cutting the umbilical cord too close to the cord clamp resulting in slippage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033554-2015-00003 |
| MDR Report Key | 4732986 |
| Report Source | 06,07 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-21 |
| Date of Event | 2012-11-05 |
| Date Facility Aware | 2012-11-05 |
| Report Date | 2015-04-21 |
| Date Mfgr Received | 2012-11-06 |
| Date Added to Maude | 2015-06-08 |
| 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 Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8643622333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAMP |
| Generic Name | DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2015-04-27 |
| Catalog Number | 6833 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 700 MARTIN LUTHER KING, JR. BLVD. SANFORD FL 32771 US 32771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-27 |