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.
[5749353]
When the clamp was placed on the baby the clamp slid off. Product purchased from professional hospital supply in a kit. Lot was not known.
Patient Sequence No: 1, Text Type: D, B5
[13263050]
Investigation findings: initial investigation: deroyal is the mfr of finished good 6833, umbilical cord clamp, which has a report of "when the clamp was placed on the baby, the clamp slid off". The bom was reviewed, on 06/12/2012, and raw material (b)(4) was identified. The raw material is a vendor supplied product. Confirmation on vendor needed prior to a scar being issued. Due to multiple vendors listed in the jde operating system, the qc complaint specialist requested assistance from the qc to identify the vendor. The qc reviewed the past products received in (b)(4). Determined the vendor was (b)(4). A car was issued on 06/14/2012. The vendor issued the completed car on 08/06/2012. In addition, the qc complaint specialist reviewed the 2010, 2011, and 2012 sales info and call history logs. Deroyal has sold (b)(4) each of raw material (b)(4), umbilical cord clamps. The call history log review found similar reports. 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 returned to deroyal and provided to (b)(4) for eval. This info is documented within the sample retrieval process of the initial complaint investigation worksheet; due to receiving (b)(4) during the investigation process of (b)(4) and had the same failure mode; therefore, (b)(4) was notified of the new event. The additional report, (b)(4), contained a lot number (the lot number was not identified for call (b)(4)); lot info was added to the deroyal plastics group problem analysis report and car response that was completed for call (b)(4); within the car response it is detailed that a design change was implemented 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); in addition, 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033554-2015-00001 |
| MDR Report Key | 4732988 |
| Report Source | 06,07 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-21 |
| Date of Event | 2012-06-05 |
| Date Facility Aware | 2012-06-05 |
| Report Date | 2015-04-21 |
| Date Mfgr Received | 2012-06-11 |
| 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 |
| Product Code | FOD |
| Date Received | 2015-04-27 |
| Returned To Mfg | 2012-07-09 |
| Catalog Number | 6833 |
| 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 | 2015-04-27 |