MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-04 for UMBILICAL CORD CLAMP 6833 manufactured by Deroyal Industries.
[19499607]
(b)(6) has gotten switched to the deroyal umbilical cord clamps and they are having issues. Clamps are sliding off, they are having to double clamp the umbilicus. They said staff are commenting that the deroyal clamp does not have the tension that their previous clamp provided.
Patient Sequence No: 1, Text Type: D, B5
[19775650]
Investigation findings: initial investigation of call (b)(4) in which the call was identified as being a memo to: deroyal is the manufacturer 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 (b)(4) 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 6/14/2012. The vendor issued the completed car on 8/6/2012. In addition, the qc complaint specialist reviewed the 2010, 2011, and 2012 sales information 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. The call was not previously identified as a (b)(4). During the evaluation of the complaint a request was received from deroyal regulatory to transition the call to (b)(4) status upon re-opening. The initial investigation of the reported issue identified that the complaint was identified as a memo to call (b)(4). The previous investigation findings for call (b)(4) are contained within this worksheet and the (b)(4) complaint file. A car was issued to (b)(4) to address the issue of umbilical cord clamp slippage issues. Within the car response it is detailed that a design change was implemented in 6/2012 and approved through (b)(4). The first lot number produced after the implemented changes was identified as lot number 12061431. Since the reporting customer provided finished good lot number, 27729862, it was confirmed that the manufacturing date was prior to the implemented changes the actions taken as a result of the car response would be acceptable in addressing this report. In addition, lot mapping was performed and identified raw material (b)(4) lot number 11070531 as being contained within the finished good. De royal also evaluated the clamp compression force of the device through validation protocol (b)(4) - comparative testing of cord clamp compression force. 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. Deroyal utilizes raw material (b)(4) within multiple product lines and multiple branch plants. Correction: a correction has not been taken. Root cause analysis: initial investigation of call (b)(4) in which the call was identified as being a memo to: refer to the attached car response. Evaluation results/root cause deroyal plastics group: the lot history record for the referenced lots was reviewed and it was confirmed that the lots met all specifications prior to release. As due diligence, and inventory verification was performed and it was identified that no product remained on hand for these lots. A recent study conducted by engineering, where cord clamps were submitted to a series of test reveals that "during testing, no failures were observed of either the latching mechanism or hinge. " 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: initial investigation of call (b)(4) in which the call was identified as being a memo. Updated: as a result of an engineering study, an opportunity 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: initial investigation of call (b)(4) in which the call was identified as being a memo. 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 | 1033554-2015-00011 |
| MDR Report Key | 4749174 |
| Report Source | 06 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-04-30 |
| Date of Event | 2012-08-23 |
| Date Facility Aware | 2012-08-23 |
| Report Date | 2015-04-30 |
| Date Mfgr Received | 2012-08-23 |
| Date Added to Maude | 2015-06-15 |
| 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 |
| Generic Name | DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2015-05-04 |
| Catalog Number | 6833 |
| Lot Number | 2322982 INCORRECT |
| 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 |