MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-05-04 for UMBILICAL CORD CLAMP, NON-STERILE 6833NS manufactured by Deroyal Industries.
[5823556]
Customer stated they received several clamps that appear to be defective (clamps won't stay shut, after initial clamping).
Patient Sequence No: 1, Text Type: D, B5
[13327601]
Investigation findings: deroyal has sold (b)(4) cases of product 6833ns; which has a report of the "several clamps that appear to be defective clamps won't stay shut after initial clamping". The samples are not available for the product. Catalog information is available. See attached. The call history logs were reviewed for similar complaints. No similar complaints have been received. The vendor was issued a scar on 1/9/2012. Follow up dates were noted within the scar log as 1/22/2012 and 1/31/2012. On 1/31/2012 the vendor requested additional time. The vendor issued a response on (b)(4) 2012. For additional investigation findings please refer to the attached car response. Correction (action taken to correct the issue and contain the problem): a correction has not been made at the present time. Root cause analysis: the lot history record for the reference lot was reviewed and it was confirmed that the lots met all specifications prior to release. Given the part in question was not returned for evaluation, it is not possible to perform an in depth investigation. As due diligence, an inventory verification was performed and it was identified that no product remained on hand for this lot. A recent study conducted by engineering, where cord clamps where submitted to a series of tests reveals that "during testing, no failures were observed of either the latching mechanism or hinge. " given that a sample was not submitted for evaluation, it is not possible to determine the cause of the reported incident. Updated: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 during the manufacturing process; 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 of the clamp. Corrective action and/or systemic correction action taken: refer to the attached car response. Updated: as a result of an engineering study, an opportunity was identified. The main improvement was identified. The main improvement was having more curve to the tooth profile. It was decreased from a radius of 19. 1 inches to a radius of 11 inches. This adds to the closing force and keeps more pressure in the center of the clamp. The secondary change was adding about. 015 inches of added height to the back rid. This should make the clamp have a slightly higher closing force. The first lot number manufactured after the changes have been identified as lot 12061431. Preventive action- refer to the attached car response. Updated: due to the investigation and root cause determination a preventive action has not been taken. This report is being filed due to a retrospective review of complaints. This complaint has been re-opened for further investigation. A supplemental report will be filed if further investigation provides information which changes the content of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033554-2015-00004 |
| MDR Report Key | 4749184 |
| Report Source | 06,07 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-04-30 |
| Date of Event | 2012-01-05 |
| Date Facility Aware | 2012-01-05 |
| Report Date | 2015-04-30 |
| Date Mfgr Received | 2012-01-05 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2015-06-17 |
| 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 | 8653622333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAMP, NON-STERILE |
| Generic Name | DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2015-05-04 |
| Catalog Number | 6833NS |
| Lot Number | 26945096 |
| 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 | 2015-05-04 |