MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-19 for AMEDA DUAL SHORT-TERM HYGIENIKIT SKU 17115 manufactured by Ameda, Inc..
[185910118]
This memo documents the results of the investigation for complaint case file (b)(4). In the initial complaint description, the user reported that a short term eco hygienikit 25 mm breast flange from product lot #9g14 caused a tiny laceration on the left nipple face near 11 o'clock (upper lateral). This event occurred while mom was pumping with a new set of 25 mm short term flange she received from the hospital where she is employed. Reviewing the device history record (dhr) for lot #9g14, the specific component, 5300036 25mm eco flange, was traced to production by seisa plastics under either lot 49931-10 or 51039 as documented in the seisa medical dhr. An investigation was initiated in coordination with seisa medical, for which seisa issued scar 2020-001 and in process inventory of 5300036 was placed on production hold. The results of the scar investigation found that while inventory of 5300036 had similar features in the flange tunnel, both the returned sample and the existing inventory were within tolerance of the set inspection point for minor defects in mspec-5300036 [1] of "sharp edges or flash >0. 25mm. " the production mold, which was validated on according to seisa medical protocol 318-02-001 and approved february 22, 2018, was inspected and there was no deterioration of the mold identified. Additionally, based on the design of the manufacturing process and associated mold, a degree of flash is inherent to the process, and is considered acceptable when in line with the criteria listed above. This complaint is the first documented instance of this particular hazard and harm at ameda for this product component. The product that this component is incorporated in is primarily intended for short term use (72 hours) market, and was used as a temporary replacement for their primary pump kit components. Based on this short term use and current rate of occurrence with a relatively low severity for the reported injury, no additional corrective action is needed at this time. Complaints and reports of this injury type will be monitored going forward for changes in occurrence that would indicate the need for corrective action in order to mitigate risk of this user harm.
Patient Sequence No: 1, Text Type: N, H10
[185910119]
Customer contacted ameda, inc. On (b)(6) 2020 to report she sustained a minor injury while pumping with her ameda finesse breast pump using a short term eco hygienikit. She explained she had forgotten her kit at home on (b)(6) 2020 and there are eco kits (used for short term pumping needs) available to use at the hospital in which she works. She used a new eco short term kit to pump that day with her ameda pump and saw blood tinged milk inside her milk container after pumping. Customer inspected her nipples and found she sustained a small laceration along the upper lateral side of her left nipple face. She reports minor discomfort and applied a lanolin based product to this laceration to aid healing. Inspection of the 25 mm eco flanges by customer revealed both flanges have a sharp edge toward the output end of the tunnel. Customer was shipped a hygienikit (not eco kit) as an additional product she can keep at work for her pumping needs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009974348-2019-00348 |
| MDR Report Key | 9729609 |
| Report Source | CONSUMER |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-07-15 |
| Date Added to Maude | 2020-02-19 |
| 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 | MRS. LINDA ZAGER |
| Manufacturer Street | 485 HALF DAY RD. SUITE 320 |
| Manufacturer City | BUFFALO GROVE, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 9642620261 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMEDA DUAL SHORT-TERM HYGIENIKIT SKU 17115 |
| Generic Name | SHORT TERM MILK COLLECTION SYSTEM |
| Product Code | HGX |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-02-04 |
| Model Number | 17115 |
| Catalog Number | 17115 |
| Lot Number | 9G14 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMEDA, INC. |
| Manufacturer Address | 485 HALF DAY RD. SUITE 320 BUFFALO GROVE, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |