MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2016-03-16 for BAG SET, 500ML, ENFITCONNECTOR INF0500-A manufactured by Moog Medical Devices Group.
[40411047]
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. Moog 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, moog 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 moog has not received any additional information indicating that a patient was or may have been harmed as a result of the reported event. Moog 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. Mmdg 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 (inf0020, inf0500, inf1200 and gr1200). 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. Mmdg 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
[40411048]
The initial reporter stated the following: i am still experiencing multiple problems with these bags. Most of the time it is the clear hard plastic part that breaks in half now and will not allow the pump to distribute patient's liquid diet. More often now (about three times/month) the feed will leak out of the end of the tubing due to a crack in the 'purple' hard plastic end (that joins to the white hard plastic end). This week i had a small pin hole in the actual bag itself, but as long as i kept the bag upright, i was able to use the bag for the feeds. Unless i am able to gravity feed (which patient's high school will not do), the clear hard plastic breaking requires me to use a new bag. If the end has cracked (purple piece) i cannot use the bag either way. Reporter did not provide a specific date the event had occured; they just said it was an "ongoing" problem. (b)(4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00365 |
| MDR Report Key | 5503631 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2016-03-16 |
| Date of Report | 2016-03-14 |
| Date Mfgr Received | 2015-11-06 |
| Device Manufacturer Date | 2015-03-13 |
| Date Added to Maude | 2016-03-16 |
| 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, 500ML, ENFITCONNECTOR |
| Generic Name | ENTERAL FEEDING SET |
| Product Code | PIO |
| Date Received | 2016-03-16 |
| Model Number | INF0500-A |
| Catalog Number | INF0500-A |
| Lot Number | CF1507206 |
| Device Expiration Date | 2018-03-13 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 2016-03-16 |