MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-04 for UMBILICAL CORD CLAMP 6833-B manufactured by Deroyal Industries.
[5824033]
The clamp ends are not meeting when closing clamp.
Patient Sequence No: 1, Text Type: D, B5
[13450273]
Investigation findings: deroyal is the manufacturer of finished good 6833-b, umbilical cord clamp 1000/cs, which has a report of "there have been a number of clamps where the ends are not meeting when they are trying to close the clamps. " the work order review identified the raw material and lot number in reference to the report. Raw material (b)(4)lot number 11112631, was identified. The raw material is a vendor supplied product. The vendor, (b)(4), was issued (b)(4) for the report. The samples were received and forwarded to (b)(4) to assist in the investigation. (b)(4) issued the (b)(4) response on 11/12/2012. In addition, the qc complaint specialist reviewed the sales information, call history logs, and scar logs. Deroyal has sold (b)(4) cases of finishing good 6833-b from 2011 to current. The call history logs and scar logs review found no similar reports for the finished good or raw material (b)(4). Correction (action taken to correct the issue and contain the problem): two cases of replacement product were shipped on order #(b)(4). Root cause analysis (why did problem occur? ): the lot history record for the reference lot was reviewed and it was confirmed that the lot met all specifications prior to release. The samples returned for evaluation were visually inspected, and no defects were identified. The samples provided closed and latch with no problem. A recent study conducted by engineering, where cord clamps where submitted to a series of tests revealed that during testing, no failures were observed of either the latching mechanism or hinge. Corrective action and/or systemic correction action taken (these are actions for the existing issue. ): as a result of the engineering study, an opportunity for improvement was identified. A curve to the tooth profile 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. A secondary change was adding. 015 inches of height to the back rib to have a slightly higher closing force. Thi was documented and approved in engineering change order (b)(4). The first lot after the mentioned improvement is lost (b)(4). 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 | 1033554-2015-00006 |
| MDR Report Key | 4749177 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-04-30 |
| Date of Event | 2012-07-05 |
| Date Facility Aware | 2012-07-15 |
| Report Date | 2015-04-30 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2015-06-11 |
| 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 | 700 BEVIER RD. |
| Manufacturer City | SANFORD FL 32771 |
| Manufacturer Country | US |
| Manufacturer Postal | 32771 |
| Manufacturer G1 | CRITICAL DISPOSABLES, INC. |
| Manufacturer Street | 700 BEVIER RD. |
| Manufacturer City | SANFORD FL 32771 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32771 |
| 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 | 2015-05-04 |
| Returned To Mfg | 2012-07-30 |
| Catalog Number | 6833-B |
| Lot Number | 28843739 |
| Device Expiration Date | 2017-03-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |