MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for BIOSEAL 9318/100 manufactured by Bioseal.
[51058409]
A complaint was reported for soloncae non-sterile 3" cotton tip applicator (cta) item code# 56100 lot number 66775 which was sold to (b)(4). The following information was initially reported: "customer reported a splinter fell off an applicator and into patient's eye during surgery". The splinter was removed with neither patient injury nor additional medical intervention being reported. The (b)(4) complaint was received on 13-nov-2015 and has been logged as a product quality complaint under (b)(4). At the time of reception of the quality complaint, an evaluation was performed and it was determined that additional information was required in order to complete the investigation. Therefore, a questionnaire was forwarded to the complainant on (b)(6) 2015. Responses obtained from complainant are delineated below. Date of the event: (b)(6) 2015. Complainant occupation: scrub tech/surgeon. Patient sex/ age: female, (b)(\6) years. Is it the first time use of product: no. Frequency details: happened 2 times before. Since it happened, we are more careful and observant when we using it. Type of medical attention sought if required, such as hospitalization, treatment and medication: no information provided. How is the patient? No information provided, any medical intervention was required to remove the splinter? Removed using forceps. Which procedure was followed to use the product? No information provided. Any details related to this incident? No additional information provided. Multiple requests were made to the complainant with respect to clarification related to the statement of frequency of occurrence indicated above and manner of usage. A response was obtained on 15-january-2016 whereby it was confirmed that the same scenario occurred with the same (b)(4) products. No other additional information was provided. Samples were received from (b)(4) related to the nature of the complaint. Upon inspection of the samples and packaging it was noted that soloncare 56100 was processed (repackaged and sterilized) by (b)(4) into item code 9318/100 (i. E. Packaging under the label of (b)(4)). (b)(4) item code 9318/100 was marketed as a sterile product. Therefore, it can be considered that soloncare 56100 (non-sterile) was used as raw material in the manufacturing of (b)(4) item code 9318/100 (sterile) and has undergone additional manufacturing processes. Since soloncare is also marketed as a finished product an investigation was requested from the manufacturing site. The nature of the complaint and all relevant information was communicated to the manufacturing facility (b)(4). An investigation was performed by the manufacturing facility, as follows: investigation: review of the inspection and production records (dhr) indicated that complained product was manufactured in compliance with current procedures and internal specifications. No deviations were noted during the manufacturing process. Possible root cause related to soloncare item code 56100: failure of the employees to detect defective product during the manufacturing process. Limitation of current production process requires visual inspection in order to remove any possible nonconforming product correctives/ preventives actions: inform all production operators, production supervisors and qc inspectors of the reported complaint. Stricter supervision by production supervisor and qc inspectors of the employees during the production process to ensure proper removal of any non-conforming finished product. Re-training of operational personnel in the evaluation of non-conforming finished product. In addition, to the actions implemented by (b)(4), decided to tighten 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 was reported from any other users for this lot or any other lots of soloncare 56100. As a finished product. Additional investigation would be required by the manufacturer (b)(4) of the marketed finished product item code 9318/100.
Patient Sequence No: 1, Text Type: N, H10
[51058410]
Customer reported splinter fell off an applicator and into patient's eye during surgery. The patient was not injured the splinter fell onto the top of the patient's eye during cataract surgery and the surgeon picked it up with forceps to remove it. Cataract surgery was successful
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611959-2016-00002 |
| MDR Report Key | 5814208 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-20 |
| Date of Event | 2015-10-21 |
| Date Facility Aware | 2015-11-13 |
| Report Date | 2015-11-13 |
| Date Reported to Mfgr | 2015-11-13 |
| Date Mfgr Received | 2015-11-13 |
| Device Manufacturer Date | 2015-04-01 |
| 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 | BIOSEAL |
| Generic Name | COTTON TIP APPLICATOR 3" |
| Product Code | KXG |
| Date Received | 2016-07-21 |
| Returned To Mfg | 2015-12-10 |
| Catalog Number | 9318/100 |
| Lot Number | 1136 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSEAL |
| Manufacturer Address | 167 W ORANGETHORPE AVE PLACENTIA CA 92870 US 92870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-21 |