MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for UMBILICUP 72-8000 manufactured by Deroyal Industries, Inc..
[74594293]
Investigation summary: an internal complaint ((b)(4)) was received indicating an umbilical cord blood collection device (part number 72-8000) failed to collect blood due to a missing needle. A sample was initially reported to be available for return. However, due to the sample being contaminated, pictures of the defective device were sent instead. The investigation is ongoing at this time. When new and critical information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[74594294]
During a c-section, the doctor noticed blood was not being collected due to the needle missing from the vacutainer. The doctor needed to use a syringe to collect the cord blood. The hospital staff x-rayed the patient to determine if the needle fell off into the patient.
Patient Sequence No: 1, Text Type: D, B5
[77257504]
Root cause: based on the investigation, a possible root cause of assembly error has been identified. The operator may have failed to assemble the needle on the collection device and a visual inspection was not properly made. Corrective action: the operator who assembled the reported work order is no longer working in this manufacturing area. The actual operators have been made aware of the reported incident. Operators were task trained to ensure all components are complete and correctly assembled on the collection devices. Investigation summary. An internal complaint (call 40513) was received indicating an umbilical cord blood collection device (part number 72-8000) failed to collect blood due to a missing needle. A sample was initially reported to be available for return. However, due to the sample being contaminated, pictures of the defective device were sent instead. The device history record for the reported lot number was verified and no issues were found when the product was assembled. As part of the investigation process, a brainstorming exercise was performed in accordance with the internal complaint handling procedure to identify a possible root cause as to why the needle was missing from the cord blood collection device. The complaint log was reviewed for the time period of (b)(6) 2015, to (b)(6) 2017, and one related internal complaint was identified. During the same time period, a total of 10,836 cases or 1, 803,000 eaches for the part number in reference have been sold. The complaint-to-sales ratio for this period of review is 0. 00000055. Preventive action: an engineering change order (eco 45389) was requested to add to the device routing steps that all operators complete an inspection of the assembled products to ensure the components are complete and correctly assembled. The investigation is complete at this time. If new and critical information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[77257505]
During a c-section, the doctor noticed blood was not being collected due to the needle missing from the vacutainer. The doctor needed to use a syringe to collect the cord blood. The hospital staff x-rayed the patient to determine if the needle fell off into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2017-00014 |
| MDR Report Key | 6543556 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-05-04 |
| 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 Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICUP |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS |
| Product Code | KSR |
| Date Received | 2017-05-04 |
| Model Number | 72-8000 |
| Lot Number | 43836799 |
| 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, INC. |
| Manufacturer Address | 1703 HIGHWAY 33 SOUTH NEW TAZEWELL TN 37825 US 37825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |