MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-03-14 for BAG SET, ENFITCONNECTOR NOT PROVIDED manufactured by Moog Medical Devices Group.
[40304150]
The device in question is new to the market. It is one of the first enteral bag/administration sets to incorporate the new enfit connectors, which were specifically designed to be exclusively compatible with enteral feeding tubes. (b)(4) is one of the first companies to bring enfit connector-containing products to the market, but others will shortly follow suit. In fact, the enfit connectors are scheduled to become the industry standard over the course of 2015, with the older christmas-tree-style connectors scheduled to be phased out of the industry by early 2016. Since the introduction of the new enfit connector-containing enteral feeding sets earlier this year, (b)(4) has received a number of complaints about the new sets, the most common being that they leak in the vicinity of the purple enfit connector piece and the white transitional stepped connector. No injury to a patient was alleged in this particular complaint, and (b)(4) has not received any additional information indicating that a patient was or may have been harmed as a result of the reported event. (b)(4) would not normally submit an mdr for this event, but is doing so now because this particular issue (leaky enfit connector) has caused a reportable injury to a patient within the last two years. The complainant did not return the affected set(s) for evaluation. The complainant did not provide a model number or lot number for the device. (b)(4) will cease production of all its enteral administration sets using enfit connectors and transition back to the previous revision of the product codes that do not include the enfit connector ((b)(4)). The previous revision includes neither the enfit connector nor the transitional connector. This revision does not exhibit the same degree of leaking, nor has it experienced any adverse reaction to formula ingredients. (b)(4) will produce the previous revision until a suitable solution to the enfit connector material degradation problem is found.
Patient Sequence No: 1, Text Type: N, H10
[40304151]
The initial reporter stated the following: leaking and loose fitting connection. The reporter did not provide lot specific information or a specific date the event occured. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00305 |
| MDR Report Key | 5499451 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-03-14 |
| Date of Report | 2016-03-14 |
| Date Mfgr Received | 2015-05-15 |
| Date Added to Maude | 2016-03-14 |
| 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 | MR. MATT BRINKERHOFF |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012641001 |
| Manufacturer G1 | MOOG MEDICAL DEVICES GROUP, SRL |
| Manufacturer Street | COYOL FREE ZONE AND BUSINESS PARK |
| Manufacturer City | ALAJUELA, SAN JOSE 20113 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20113 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1722139-11/19/15-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAG SET, ENFITCONNECTOR |
| Generic Name | ENTERAL FEEDING SET |
| Product Code | PIO |
| Date Received | 2016-03-14 |
| Model Number | NOT PROVIDED |
| Catalog Number | NOT PROVIDED |
| Lot Number | NOT PROVIDED |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Address | 4314 ZEVEX PARK LANE SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-14 |