MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for SOLONCARE 56201 manufactured by Amd Medicom Inc..
[51004624]
A complaint was reported for brand product solon 6in cotton tipped applicators (cta) plastic product code# 56201 in which the following information was initially reported: "customer reported issue with their lap general tray, component cotton applicator tip fell off inside of patient". The applicator is classified as a class 1 device, under fda code kxg whose intended use is as follow: to apply medications to, or to take specimens from, a patient. The complaint was received on 17-sep-2015 and logged as finished product quality complaint (b)(4). A request for investigation was made to the manufacturing facility based on the information received at that time. No other complaint of this nature was reported. In addition, the cotton bud was removed with neither patient injury nor additional medical intervention being reported. At the time of reception of the quality complaint, an evaluation was performed and it was deemed that additional information was required. A questionnaire was forwarded to the complainant on 21-sep-2015. Any medical intervention required? Which procedure was followed to use the product? Any particular observations noticed related to this incident? The complainant indicated, on 22-sep-2015, that previously multiple attempts had been made (i. E. At least 4 emails and 2 phone calls since (b)(6) 2015) to obtain clinical data from the end-user. It was communicated by the end user that due to the time at which the event took place (off-hours) it was difficult to obtain any further information/clarification from end-user present at the time of the event. The only additional information communicated by the end user and provided on 12-oct-2015 was that the "cotton-tipped applicator fell off inside patient during general laparoscopy". No further clarification/information was provided. Since, no further details were to be received, the investigation was performed by the manufacturing facility (b)(6) based on the available information: review of the dhr indicated that complained product was manufactured in compliance with current procedures and internal specifications. No deviations were noted during the manufacturing process. Product complies with requirement for "bud tightness "inspection as per finished product specification. Production process of cta plastic item code# 56201 is as follow: shafts are heated by machine and are scored (usually 3 circles) initially at one end of the shaft, then proceeds to the next step in the manufacturing process whereby the cotton is winded to the shaft. Probable cause for loose bud would be that the scores for this applicator were not deep enough to hold the buds tightly. Based on the above investigation the following correctives/ preventives actions were immediately implemented: inform all production operators, production supervisors and qc inspectors of the nature of the complaint. Improve the manufacturing process; whereby medical grade glue is added to the shaft which has been initially scored prior to winding the cotton to the shaft. Re-train the operators and inspectors on the new process. Emphasis on daily verification during the production and quality inspection process, to avoid non- conforming products being packed. In addition to the actions implemented by (b)(6). , (b)(4) decided to tight its inspection level of its finished product prior to release as indicated below: increase single sampling plan from normal to tightened increase inspection level from s4 to gi. It should be noted that at this time, no other complaints of this nature has been reported from any other users which confirmed the effectiveness of the corrective actions implemented. Not returned by end-user for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[51004625]
Customer reported issue with their lap general tray. Component cotton tip applicator fell off inside a patient. No patient injury customer has indicated that a sample is not available for this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611959-2016-00001 |
| MDR Report Key | 5814209 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-20 |
| Date of Event | 2015-09-17 |
| Date Facility Aware | 2015-09-17 |
| Report Date | 2015-09-17 |
| Date Reported to Mfgr | 2015-09-17 |
| Date Mfgr Received | 2015-09-25 |
| Device Manufacturer Date | 2014-10-27 |
| Date Added to Maude | 2016-07-21 |
| 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 | MS DOMINIQUE ABECASSIS |
| Manufacturer Street | 1200 55TH AVENUE |
| Manufacturer City | MONTREAL (LACHINE), QUEBEC H8T 3J8 |
| Manufacturer Country | CA |
| Manufacturer Postal | H8T 3J8 |
| Manufacturer Phone | 6331111 |
| Manufacturer G1 | GOODWOOD MEDICAL CARE |
| Manufacturer Street | 1-2 FLOOR, 3-919 JIULICUN YONGZHENG STREET |
| Manufacturer City | JINZHOU DISTRICT, DALIAN LIAONING 116100 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 116100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOLONCARE |
| Generic Name | NON-STERILE COTTON TIP APPLICATOR |
| Product Code | KXF |
| Date Received | 2016-07-21 |
| Catalog Number | 56201 |
| Lot Number | 67209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMD MEDICOM INC. |
| Manufacturer Address | 1200 55TH AVENUE MONTREAL (LACHINE), QUEBEC H8T 3J8 CA H8T 3J8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-21 |