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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSEAL BIOSEAL; COTTON TIP APPLICATOR 3"

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BIOSEAL BIOSEAL; COTTON TIP APPLICATOR 3" Back to Search Results
Catalog Number 9318/100
Device Problems Break (1069); Material Fragmentation (1261); Product Quality Problem (1506)
Patient Problem Not Applicable (3189)
Event Date 10/21/2015
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand Name
BIOSEAL
Type of Device
COTTON TIP APPLICATOR 3"
Manufacturer (Section D)
BIOSEAL
167 w orangethorpe ave
placentia CA 92870
Manufacturer (Section G)
GOODWOOD MEDICAL CARE
1-2 floor, 3-919 jiulicun
yongzheng street
jinzhou district, dalian liaoning 11610 0
CH   116100
Manufacturer Contact
dominique abecassis
1200 55th avenue
montreal (lachine), quebec H8T 3-J8
CA   H8T 3J8
6331111
MDR Report Key5814208
MDR Text Key51058409
Report Number9611959-2016-00002
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other
Type of Report Initial
Report Date 11/13/2015,07/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9318/100
Device Lot Number1136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2015
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer11/13/2015
Date Manufacturer Received11/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
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