|
On 22-oct-2018, a medwatch was reported to the fda by amd medicom which refers to amd-ritmed brand gauze sponge non-sterile product a3006-10.The following event was reported: "have you guys changed the brand of 4x4's in the pack? they are shedding really bad.I actually had a piece stick to a wire and it went down the pts artery and caused a huge thrombus.We have noticed that they're shedding for maybe 6-8 weeks.We are now having to throw away the ones in the pack and open new ones" customer complaint was received by amd medicom on 19-oct-2018 and was logged as product quality complaint (b)(4).At the time of reception of the quality complaint, an evaluation was performed by amd medicom and it was determined that additional information was required in order to complete the investigation.Therefore, a questionnaire was forwarded to the complainant and a response obtained as detailed below: -can you please describe in detail the procedure that the patient went through? peripheral angiogram with balloon angioplasy of the superficial femoral artery -was the product used by a healthcare professional? yes -is this the first time the device was used by the healthcare worker? no -if not, how long the device has been in use? when was it used previously? the products we used during the procedure are a onetime sterile use.We are extremely familiar with all of the devices we used -have there been any previous problems with this item? if yes how often have these problems occurred? was it from the same lot# many of the 4x4's have exhibited some type of shredding? same lot number -how many other units of the device were involved in the incident? no response provided by customer -was the device misused in any way (for example: reuse of a single-use device)? it was 4x4's.How can we misuse them? -the patient (gender, age or date of birth) female; age: 68; dob: 09-25-1949 -weight: 145 pounds -the patient history of allergy (details: list known food/drug allergies) none -patient use of medications in general (prescription & other) no response provided by customer -type of medical attention sought if required, such as hospitalization, medical or surgical treatment, and or medication - case became prolonged due to extended time needed for thrombus retrieval in superficial femoral artery.More heparin had to be given intravenously -event description (e.G.Symptoms): thrombus formation in superficial femoral artery (sfa) due to foreign body.-- an embolic protection device (medtronic spider fx) was already placed in the distal part of the patient's leg at the beginning of the procedure for routine atherectomy/angioplasty procedure.(we had been noticing for the prior month that the 4x4's had been "shedding" throughout the procedure.We thought that they we more of a nuisance at that time) at one point in the procedure we found that there was a long thrombus in the sfa.We had to give the patient more iv heparin.We tried manual aspiration thrombectomy, atherectomy and balloon angioplasty, with no relief.We had to give more heparin and alteplase to the patient directly down the vessel.After 2 hours we finally got some resolve of the thrombus.Once i retrieved the spider embolic device there was "2 thread like particles" within the spider.This spider device is used to "catch" any plaque or that is washed distally due to angioplasty or atherectomy.Thankfully we had it in place as a normal precaution during our procedures.Otherwise the "particles" could have gone more distally into the patient's arteries below the knee requiring surgery or ischemic reaction.-duration of symptoms: 2.5 hours -date of use: 9-4-18 -indication for use: it as gauze 4x4's in our catheterization procedure pack -can you please send us some defective samples? we remove all of the 4x4's on the packs before we start the procedure.Am has sent us replacement sterile gauze packs to use in place until we get the issue resolved.We have saved some of the gauze for non-sterile use like over an iv site/under band-aid, etc.I can send some of the gauze but i'm not sure it is from the same lot # as the one in question in addition, a request was made by amd medicom to the complainant for the return of the item code a3006-10 lot 76537; however, no product was returned by the complainant or samples provided.The client did not have any inventory of this item and lot number since sample and/or pictures were not available, the investigation performed was based on a review of the gauze material used and the production process.The outcome of the quality investigation is delineated below: -item a3006-10 is non-sterile gauze swab (4"×4"-12p, edge not folded), packed as 200pcs/bag, 10 bags/cs.The production process is as follow: obtain gauze roll material, swab folding, packing, packing into cases, final inspection, entering warehouse -review of the dhr indicated that lot 76537 was manufactured in compliance with current procedures and internal specifications.No deviations or changes were noted during the manufacturing process -the gauze material with specification of 32s×32s/19×9-27cm, with one weaving edge and one cutting edge.The slitting method of gauze was improved in august 2015, to reduce lint generated from the cutting edges.The complained batch was manufactured after the implementation of the improvement -the retained sample of the complained lot was verified, no lint was found on the surface or after unfolding the swab -a shaking test as per internal sop lint testing standard for gauze products was performed.No fraying edge was found.The results of shaking test were as follow: three (3) lint particles with a size greater than 1mm were found.Based on current specification, the product meets acceptance criteria -according to characteristic of this type of raw materials and production process, there is a certain amount of lint generated during the slitting process, however the presence of this lint cannot be completely removed in the post-manufacturing process.Measures have been taken to reduce this lint to the greatest level, but zero defect cannot be guaranteed at this time -notification to workshop personnel of the complaint and emphasized the requirement of self-check and mutual-check -a review of all complaints received by amd medicom over the last two (2) years has indicated that there was no other complaint received with respect to this product and the nature of the complaint.Based on the above investigation, it can be considered that the product was manufactured, packaged, labeled, inspected and released in accordance with product specification and the most probably cause is related to the manner of usage of the product.
|
